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NCT01147016

Targeted T Cells After Neoadjuvant Chemotherapy in Treating Women With Stage II or III Breast Cancer Undergoing Surgery

Version 18 to 19 · Barbara Ann Karmanos Cancer Institute

Patch inspector

Version 18 to 19

24 operations 6 path groups ctgov_internal_history
ClinicalTrials.gov
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
terminal_status_changewhy_stopped_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_actualized_earlier",
    "category": "timeline_actualized_earlier",
    "new_type": "ACTUAL",
    "old_type": "ESTIMATED",
    "severity": "low",
    "direction": "earlier",
    "new_value": "2017-07-26",
    "old_value": "2018-12",
    "delta_days": 493,
    "date_struct": "completionDateStruct",
    "new_precision": "day",
    "old_precision": "month"
  },
  {
    "paths": [
      "/protocolSection/outcomesModule/primaryOutcomes/0/description",
      "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
      "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
      "/protocolSection/outcomesModule/primaryOutcomes/1",
      "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
      "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
      "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame"
    ],
    "signal": "results_reconciliation_outcome_suppression",
    "category": "results_reconciliation",
    "severity": "low"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:13:31+00
Raw hash
9b6c7f6485e8daa25afd47cbe36cf6f7981086283bb15fcc03b5f00942dd3f66
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 4 ops
replace /protocolSection/outcomesModule/primaryOutcomes/0/measure
Triage: Critical
Primary Outcome Change Operation 14
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Pathologic complete response
After
Progression-free Survival
replace /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
Triage: Critical
Primary Outcome Change Operation 15
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Every 8 weeks or as indicated
After
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years..
add /protocolSection/outcomesModule/primaryOutcomes/0/description
Triage: Critical
Primary Outcome Change Operation 16
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
After
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion
remove /protocolSection/outcomesModule/primaryOutcomes/1
Triage: Critical
Primary Outcome Change Operation 17
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
{
  "measure": "Recurrence-free survival",
  "timeFrame": "Every 8 weeks or as indicated"
}
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 3 ops
replace /protocolSection/outcomesModule/secondaryOutcomes/0/measure
Triage: High
Secondary Outcome Change Operation 18
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Overall survival
After
Overall Deaths
replace /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame
Triage: High
Secondary Outcome Change Operation 19
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Every 3 months for the first year, and then every 6 months for one more year.
After
From date of randomization until date of death from any cause or end of study, whichever came first, assessed up to 7 years
add /protocolSection/outcomesModule/secondaryOutcomes/0/description
Triage: High
Secondary Outcome Change Operation 20
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
Total number of deaths
Status and stopping reason Recruitment status, termination, suspension, withdrawal, or why-stopped text. Triage: High 2 ops
replace /protocolSection/statusModule/overallStatus
Triage: High
Status Termination Operation 3
Matched rules
  • terminal_status_change Status changed to terminated, suspended, or withdrawn; whyStopped content determines whether critical review is warranted.
Before
ACTIVE_NOT_RECRUITING
After
TERMINATED
add /protocolSection/statusModule/whyStopped
Triage: High
Status Termination Operation 8
Matched rules
  • why_stopped_change Why-stopped changes explain discontinuation and need review.
After
Primary co-investigator leaving the institution & funding transfer.
Timeline Start, primary completion, and completion date movement. Triage: Medium 2 ops
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 4
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2018-12
After
2017-07-26
replace /protocolSection/statusModule/completionDateStruct/type
Triage: Medium
Timeline Shift Operation 5
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
ESTIMATED
After
ACTUAL
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 10 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2018-01
After
2023-04
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 6
Before
2018-04-13
After
2023-04-05
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 7
Before
2018-04-17
After
2023-04-27
add /protocolSection/statusModule/resultsFirstSubmitDate
Triage: Uncategorized
Uncategorized Operation 9
After
2020-12-21
add /protocolSection/statusModule/resultsFirstSubmitQcDate
Triage: Uncategorized
Uncategorized Operation 10
After
2023-04-05
add /protocolSection/statusModule/resultsFirstPostDateStruct
Triage: Uncategorized
Uncategorized Operation 11
After
{
  "date": "2023-04-27",
  "type": "ACTUAL"
}
remove /annotationSection
Triage: Uncategorized
Uncategorized Operation 21
Before
{
  "annotationModule": {
    "unpostedAnnotation": {
      "unpostedEvents": [
        {
          "date": "2020-12-21",
          "type": "RELEASE"
        },
        {
          "date": "2021-01-13",
          "type": "RESET"
        }
      ],
      "unpostedResponsibleParty": "Abhinav Deol, Investigator, Barbara Ann Karmanos Cancer Institute"
    }
  }
}
replace /hasResults
Triage: Uncategorized
Uncategorized Operation 22
Before
false
After
true
add /resultsSection
Triage: Uncategorized
Uncategorized Operation 23
After
{
  "moreInfoModule": {
    "pointOfContact": {
      "email": "aweise3@hfhs.org",
      "phone": "248-344-6688",
      "title": "Dr. Amy Weise",
      "organization": "Barbara Ann Karmanos Cancer Institute"
    },
    "certainAgreement": {
      "piSponsorEmployee": true
    }
  },
  "adverseEventsModule": {
    "timeFrame": "Up to 7 years.",
    "eventGroups": [
      {
        "id": "EG000",
        "title": "Treated",
        "description": "All 8 participants enrolled",
        "otherNumAtRisk": 8,
        "deathsNumAtRisk": 8,
        "otherNumAffected": 8,
        "seriousNumAtRisk": 8,
        "deathsNumAffected": 1,
        "seriousNumAffected": 0
      }
    ],
    "otherEvents": [
      {
        "term": "Hypertension",
        "notes": "Grade 2",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 1,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Cardiac disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      },
      {
        "term": "chills/rigors",
        "notes": "grade 1 1 grade 2 5 grade 31",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 8,
            "numEvents": 7,
            "numAffected": 7
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      },
      {
        "term": "Nausea",
        "notes": "Grade 1 5 Grade 2 1",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 8,
            "numEvents": 7,
            "numAffected": 7
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      },
      {
        "term": "Vomiting",
        "notes": "Grade 1 3 Grade 2 1",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 8,
            "numEvents": 4,
            "numAffected": 4
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      },
      {
        "term": "fatigue",
        "notes": "Grade 1 4 Grade 2 3",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 8,
            "numEvents": 7,
            "numAffected": 7
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      },
      {
        "term": "Rash",
        "notes": "Grade 1 3",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 8,
            "numEvents": 3,
            "numAffected": 3
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      },
      {
        "term": "edema",
        "notes": "Grade 1 1 Grade 2 1",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 8,
            "numEvents": 2,
            "numAffected": 2
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      },
      {
        "term": "neuroppathy",
        "notes": "Grade 1 1 Grade 2 1 Grade 3 1",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 8,
            "numEvents": 3,
            "numAffected": 3
          }
        ],
        "organSystem": "Nervous system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      },
      {
        "term": "hypotension",
        "notes": "Grade 2 5",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 8,
            "numEvents": 5,
            "numAffected": 5
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      },
      {
        "term": "fever",
        "notes": "grade 1 4 Grade 2 2",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 8,
            "numEvents": 6,
            "numAffected": 6
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      },
      {
        "term": "hyponatremia",
        "notes": "Grade 1 1",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 8,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      },
      {
        "term": "hypoglycemia",
        "notes": "Grade 1 2",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 8,
            "numEvents": 2,
            "numAffected": 2
          }
        ],
        "organSystem": "Endocrine disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      },
      {
        "term": "neutropenia",
        "notes": "Grade 1 1 Grade 2 1 Grade 3 1 Grade 4 1",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 8,
            "numEvents": 4,
            "numAffected": 4
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      },
      {
        "term": "AST elevation",
        "notes": "grade 1 1",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 8,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      },
      {
        "term": "ALT elevation",
        "notes": "Grade 1 1",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 8,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      },
      {
        "term": "Anemia",
        "notes": "Grade 1 4 Grade 2 1",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 8,
            "numEvents": 5,
            "numAffected": 5
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      },
      {
        "term": "Afibrillation",
        "notes": "Grade 2 1",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 8,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Cardiac disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      },
      {
        "term": "Diarrhea",
        "notes": "Grade 1 1",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 8,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      },
      {
        "term": "Infection",
        "notes": "Grade 1 2 Grade 2 1",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 8,
            "numEvents": 3,
            "numAffected": 3
          }
        ],
        "organSystem": "Infections and infestations",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      },
      {
        "term": "Low platelets",
        "notes": "Grade 1 3 Grade 2 2",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 8,
            "numEvents": 5,
            "numAffected": 5
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      },
      {
        "term": "hypoalbuminemia",
        "notes": "Grade 1 1 Grade 2 1",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 8,
            "numEvents": 2,
            "numAffected": 2
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      },
      {
        "term": "Alkaline Phosphatase",
        "notes": "Grade 1 1 Grade 2 1",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 8,
            "numEvents": 2,
            "numAffected": 2
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      },
      {
        "term": "Hypercalcemia",
        "notes": "Grade 1 2 Grade 2 1",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 8,
            "numEvents": 2,
            "numAffected": 2
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      },
      {
        "term": "Hypocalcemia",
        "notes": "Grade 3 1",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 1,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      },
      {
        "term": "hypokalemia",
        "notes": "Grade 1 1",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 8,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "CTCAE (3.0)"
      }
    ],
    "frequencyThreshold": "0"
  },
  "outcomeMeasuresModule": {
    "outcomeMeasures": [
      {
        "type": "PRIMARY",
        "title": "Progression-free Survival",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "8",
                "groupId": "OG000"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Activated T Cells",
            "description": "All participants enrolled"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "43",
                    "comment": "The sample size is very small and there are too few events to estimate the upper 95% CI.",
                    "groupId": "OG000",
                    "lowerLimit": "2",
                    "upperLimit": "NA"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEDIAN",
        "timeFrame": "From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years..",
        "description": "Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion",
        "unitOfMeasure": "months",
        "dispersionType": "95% Confidence Interval",
        "reportingStatus": "POSTED",
        "populationDescription": "Women with stage II-III, HER2/neu (0-2+) negative breast cancer treated with anti-CD3 x anti-HER2neu (Her2BI) armed, activated T cells after neoadjuvant chemotherapy"
      },
      {
        "type": "SECONDARY",
        "title": "Overall Deaths",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "8",
                "groupId": "OG000"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Treated",
            "description": "Single group study"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "timeFrame": "From date of randomization until date of death from any cause or end of study, whichever came first, assessed up to 7 years",
        "description": "Total number of deaths",
        "unitOfMeasure": "Participants",
        "reportingStatus": "POSTED",
        "populationDescription": "The participant who died had the longest follow-up time."
      }
    ]
  },
  "participantFlowModule": {
    "groups": [
      {
        "id": "FG000",
        "title": "Treated",
        "description": "Single group study"
      }
    ],
    "periods": [
      {
        "title": "Overall Study",
        "milestones": [
          {
            "type": "STARTED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "8"
              }
            ]
          },
          {
            "type": "COMPLETED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "8"
              }
            ]
          },
          {
            "type": "NOT COMPLETED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "0"
              }
            ]
          }
        ]
      }
    ]
  },
  "baselineCharacteristicsModule": {
    "denoms": [
      {
        "units": "Participants",
        "counts": [
          {
            "value": "8",
            "groupId": "BG000"
          }
        ]
      }
    ],
    "groups": [
      {
        "id": "BG000",
        "title": "Treated",
        "description": "Single group study"
      }
    ],
    "measures": [
      {
        "title": "Age, Continuous",
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "44.5",
                    "groupId": "BG000",
                    "lowerLimit": "39",
                    "upperLimit": "52"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEDIAN",
        "unitOfMeasure": "years",
        "dispersionType": "INTER_QUARTILE_RANGE"
      },
      {
        "title": "Sex: Female, Male",
        "classes": [
          {
            "categories": [
              {
                "title": "Female",
                "measurements": [
                  {
                    "value": "8",
                    "groupId": "BG000"
                  }
                ]
              },
              {
                "title": "Male",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Ethnicity (NIH/OMB)",
        "classes": [
          {
            "categories": [
              {
                "title": "Hispanic or Latino",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  }
                ]
              },
              {
                "title": "Not Hispanic or Latino",
                "measurements": [
                  {
                    "value": "8",
                    "groupId": "BG000"
                  }
                ]
              },
              {
                "title": "Unknown or Not Reported",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Race (NIH/OMB)",
        "classes": [
          {
            "categories": [
              {
                "title": "American Indian or Alaska Native",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  }
                ]
              },
              {
                "title": "Asian",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  }
                ]
              },
              {
                "title": "Native Hawaiian or Other Pacific Islander",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  }
                ]
              },
              {
                "title": "Black or African American",
                "measurements": [
                  {
                    "value": "4",
                    "groupId": "BG000"
                  }
                ]
              },
              {
                "title": "White",
                "measurements": [
                  {
                    "value": "4",
                    "groupId": "BG000"
                  }
                ]
              },
              {
                "title": "More than one race",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  }
                ]
              },
              {
                "title": "Unknown or Not Reported",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Region of Enrollment",
        "classes": [
          {
            "title": "United States",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "8",
                    "groupId": "BG000"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "NUMBER",
        "unitOfMeasure": "participants"
      },
      {
        "title": "enrollment",
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "8",
                    "groupId": "BG000"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      }
    ]
  }
}
add /documentSection
Triage: Uncategorized
Uncategorized Operation 24
After
{
  "largeDocumentModule": {
    "largeDocs": [
      {
        "date": "2015-05-12",
        "size": 1679294,
        "label": "Study Protocol and Statistical Analysis Plan",
        "hasIcf": false,
        "hasSap": true,
        "filename": "Prot_SAP_000.pdf",
        "typeAbbrev": "Prot_SAP",
        "uploadDate": "2020-09-30T15:45",
        "hasProtocol": true
      }
    ]
  }
}
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 3 ops
replace /protocolSection/identificationModule/orgStudyIdInfo/id
Triage: Uncategorized
Uncategorized Operation 1
Before
CDR0000675211
After
2010-056(b)
replace /protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorFullName
Triage: Uncategorized
Uncategorized Operation 12
Before
Amy Weise
After
Abhinav Deol
replace /protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorTitle
Triage: Uncategorized
Uncategorized Operation 13
Before
Principal Investigator
After
Investigator
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/orgStudyIdInfo/id",
    "value": "2010-056(b)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2023-04"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "TERMINATED"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2017-07-26"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2023-04-05"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2023-04-27"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/whyStopped",
    "value": "Primary co-investigator leaving the institution & funding transfer."
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstSubmitDate",
    "value": "2020-12-21"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
    "value": "2023-04-05"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
    "value": {
      "date": "2023-04-27",
      "type": "ACTUAL"
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorFullName",
    "value": "Abhinav Deol"
  },
  {
    "op": "replace",
    "path": "/protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorTitle",
    "value": "Investigator"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
    "value": "Progression-free Survival"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years.."
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "value": "Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion"
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/1"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
    "value": "Overall Deaths"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "value": "From date of randomization until date of death from any cause or end of study, whichever came first, assessed up to 7 years"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
    "value": "Total number of deaths"
  },
  {
    "op": "remove",
    "path": "/annotationSection"
  },
  {
    "op": "replace",
    "path": "/hasResults",
    "value": true
  },
  {
    "op": "add",
    "path": "/resultsSection",
    "value": {
      "moreInfoModule": {
        "pointOfContact": {
          "email": "aweise3@hfhs.org",
          "phone": "248-344-6688",
          "title": "Dr. Amy Weise",
          "organization": "Barbara Ann Karmanos Cancer Institute"
        },
        "certainAgreement": {
          "piSponsorEmployee": true
        }
      },
      "adverseEventsModule": {
        "timeFrame": "Up to 7 years.",
        "eventGroups": [
          {
            "id": "EG000",
            "title": "Treated",
            "description": "All 8 participants enrolled",
            "otherNumAtRisk": 8,
            "deathsNumAtRisk": 8,
            "otherNumAffected": 8,
            "seriousNumAtRisk": 8,
            "deathsNumAffected": 1,
            "seriousNumAffected": 0
          }
        ],
        "otherEvents": [
          {
            "term": "Hypertension",
            "notes": "Grade 2",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 1,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Cardiac disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          },
          {
            "term": "chills/rigors",
            "notes": "grade 1 1 grade 2 5 grade 31",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 8,
                "numEvents": 7,
                "numAffected": 7
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          },
          {
            "term": "Nausea",
            "notes": "Grade 1 5 Grade 2 1",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 8,
                "numEvents": 7,
                "numAffected": 7
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          },
          {
            "term": "Vomiting",
            "notes": "Grade 1 3 Grade 2 1",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 8,
                "numEvents": 4,
                "numAffected": 4
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          },
          {
            "term": "fatigue",
            "notes": "Grade 1 4 Grade 2 3",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 8,
                "numEvents": 7,
                "numAffected": 7
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          },
          {
            "term": "Rash",
            "notes": "Grade 1 3",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 8,
                "numEvents": 3,
                "numAffected": 3
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          },
          {
            "term": "edema",
            "notes": "Grade 1 1 Grade 2 1",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 8,
                "numEvents": 2,
                "numAffected": 2
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          },
          {
            "term": "neuroppathy",
            "notes": "Grade 1 1 Grade 2 1 Grade 3 1",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 8,
                "numEvents": 3,
                "numAffected": 3
              }
            ],
            "organSystem": "Nervous system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          },
          {
            "term": "hypotension",
            "notes": "Grade 2 5",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 8,
                "numEvents": 5,
                "numAffected": 5
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          },
          {
            "term": "fever",
            "notes": "grade 1 4 Grade 2 2",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 8,
                "numEvents": 6,
                "numAffected": 6
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          },
          {
            "term": "hyponatremia",
            "notes": "Grade 1 1",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 8,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          },
          {
            "term": "hypoglycemia",
            "notes": "Grade 1 2",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 8,
                "numEvents": 2,
                "numAffected": 2
              }
            ],
            "organSystem": "Endocrine disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          },
          {
            "term": "neutropenia",
            "notes": "Grade 1 1 Grade 2 1 Grade 3 1 Grade 4 1",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 8,
                "numEvents": 4,
                "numAffected": 4
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          },
          {
            "term": "AST elevation",
            "notes": "grade 1 1",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 8,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          },
          {
            "term": "ALT elevation",
            "notes": "Grade 1 1",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 8,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          },
          {
            "term": "Anemia",
            "notes": "Grade 1 4 Grade 2 1",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 8,
                "numEvents": 5,
                "numAffected": 5
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          },
          {
            "term": "Afibrillation",
            "notes": "Grade 2 1",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 8,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Cardiac disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          },
          {
            "term": "Diarrhea",
            "notes": "Grade 1 1",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 8,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          },
          {
            "term": "Infection",
            "notes": "Grade 1 2 Grade 2 1",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 8,
                "numEvents": 3,
                "numAffected": 3
              }
            ],
            "organSystem": "Infections and infestations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          },
          {
            "term": "Low platelets",
            "notes": "Grade 1 3 Grade 2 2",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 8,
                "numEvents": 5,
                "numAffected": 5
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          },
          {
            "term": "hypoalbuminemia",
            "notes": "Grade 1 1 Grade 2 1",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 8,
                "numEvents": 2,
                "numAffected": 2
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          },
          {
            "term": "Alkaline Phosphatase",
            "notes": "Grade 1 1 Grade 2 1",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 8,
                "numEvents": 2,
                "numAffected": 2
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          },
          {
            "term": "Hypercalcemia",
            "notes": "Grade 1 2 Grade 2 1",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 8,
                "numEvents": 2,
                "numAffected": 2
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          },
          {
            "term": "Hypocalcemia",
            "notes": "Grade 3 1",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 1,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          },
          {
            "term": "hypokalemia",
            "notes": "Grade 1 1",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 8,
                "numEvents": 1,
                "numAffected": 1
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "CTCAE (3.0)"
          }
        ],
        "frequencyThreshold": "0"
      },
      "outcomeMeasuresModule": {
        "outcomeMeasures": [
          {
            "type": "PRIMARY",
            "title": "Progression-free Survival",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "8",
                    "groupId": "OG000"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Activated T Cells",
                "description": "All participants enrolled"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "43",
                        "comment": "The sample size is very small and there are too few events to estimate the upper 95% CI.",
                        "groupId": "OG000",
                        "lowerLimit": "2",
                        "upperLimit": "NA"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEDIAN",
            "timeFrame": "From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years..",
            "description": "Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion",
            "unitOfMeasure": "months",
            "dispersionType": "95% Confidence Interval",
            "reportingStatus": "POSTED",
            "populationDescription": "Women with stage II-III, HER2/neu (0-2+) negative breast cancer treated with anti-CD3 x anti-HER2neu (Her2BI) armed, activated T cells after neoadjuvant chemotherapy"
          },
          {
            "type": "SECONDARY",
            "title": "Overall Deaths",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "8",
                    "groupId": "OG000"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Treated",
                "description": "Single group study"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "timeFrame": "From date of randomization until date of death from any cause or end of study, whichever came first, assessed up to 7 years",
            "description": "Total number of deaths",
            "unitOfMeasure": "Participants",
            "reportingStatus": "POSTED",
            "populationDescription": "The participant who died had the longest follow-up time."
          }
        ]
      },
      "participantFlowModule": {
        "groups": [
          {
            "id": "FG000",
            "title": "Treated",
            "description": "Single group study"
          }
        ],
        "periods": [
          {
            "title": "Overall Study",
            "milestones": [
              {
                "type": "STARTED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "8"
                  }
                ]
              },
              {
                "type": "COMPLETED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "8"
                  }
                ]
              },
              {
                "type": "NOT COMPLETED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "0"
                  }
                ]
              }
            ]
          }
        ]
      },
      "baselineCharacteristicsModule": {
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          {
            "units": "Participants",
            "counts": [
              {
                "value": "8",
                "groupId": "BG000"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "BG000",
            "title": "Treated",
            "description": "Single group study"
          }
        ],
        "measures": [
          {
            "title": "Age, Continuous",
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "44.5",
                        "groupId": "BG000",
                        "lowerLimit": "39",
                        "upperLimit": "52"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEDIAN",
            "unitOfMeasure": "years",
            "dispersionType": "INTER_QUARTILE_RANGE"
          },
          {
            "title": "Sex: Female, Male",
            "classes": [
              {
                "categories": [
                  {
                    "title": "Female",
                    "measurements": [
                      {
                        "value": "8",
                        "groupId": "BG000"
                      }
                    ]
                  },
                  {
                    "title": "Male",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "unitOfMeasure": "Participants"
          },
          {
            "title": "Ethnicity (NIH/OMB)",
            "classes": [
              {
                "categories": [
                  {
                    "title": "Hispanic or Latino",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      }
                    ]
                  },
                  {
                    "title": "Not Hispanic or Latino",
                    "measurements": [
                      {
                        "value": "8",
                        "groupId": "BG000"
                      }
                    ]
                  },
                  {
                    "title": "Unknown or Not Reported",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "unitOfMeasure": "Participants"
          },
          {
            "title": "Race (NIH/OMB)",
            "classes": [
              {
                "categories": [
                  {
                    "title": "American Indian or Alaska Native",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      }
                    ]
                  },
                  {
                    "title": "Asian",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      }
                    ]
                  },
                  {
                    "title": "Native Hawaiian or Other Pacific Islander",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      }
                    ]
                  },
                  {
                    "title": "Black or African American",
                    "measurements": [
                      {
                        "value": "4",
                        "groupId": "BG000"
                      }
                    ]
                  },
                  {
                    "title": "White",
                    "measurements": [
                      {
                        "value": "4",
                        "groupId": "BG000"
                      }
                    ]
                  },
                  {
                    "title": "More than one race",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      }
                    ]
                  },
                  {
                    "title": "Unknown or Not Reported",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "unitOfMeasure": "Participants"
          },
          {
            "title": "Region of Enrollment",
            "classes": [
              {
                "title": "United States",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "8",
                        "groupId": "BG000"
                      }
                    ]
                  }
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