evt_NCT03515798_v5_v6_0b625aa10e52

{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/statusModule/resultsFirstSubmitDate",
    "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
    "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
    "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/7/measure",
    "/protocolSection/outcomesModule/otherOutcomes/0/measure",
    "/protocolSection/outcomesModule/otherOutcomes/1/measure",
    "/protocolSection/outcomesModule/otherOutcomes/2/measure",
    "/protocolSection/outcomesModule/otherOutcomes/3/measure",
    "/hasResults",
    "/resultsSection",
    "/annotationSection",
    "/documentSection"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT03515798_v5_v6_0b625aa10e52. ClinicalTrials.gov NCT03515798, versions 5-6. Evidence version 1.",
  "claims_not_supported": [
    "That the amendment was scientifically unjustified.",
    "That the change constitutes misconduct or wrongdoing.",
    "That sponsor intent can be inferred from this registry change.",
    "That the change caused or altered the trial's results.",
    "That the change was or was not disclosed in a manuscript.",
    "That TrialDiff determines regulatory compliance or non-compliance.",
    "That co-occurrence with results posting proves the outcome edit was harmless, administrative, or substantively benign.",
    "That event-class membership is a validated global review-priority ranking."
  ],
  "claims_supported": [
    "TrialDiff compared ClinicalTrials.gov record version 5 to version 6 for NCT03515798.",
    "The JSON Patch for this comparison has hash 82fd4bd498b83c70e3572405e85bb98ab5d05eacca30916c6aa38f3399eef487.",
    "The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.",
    "The deterministic triage label was low; before timing adjustment it was low.",
    "The triage label is uncalibrated metadata, not a validated review-priority finding.",
    "The patch satisfied these deterministic event-class predicates: outcome_edit_cooccurs_with_results_posting.",
    "The timing context for the from-version record was late_recruitment.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit, /protocolSection/outcomesModule/primaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/2/measure, /protocolSection/outcomesModule/secondaryOutcomes/3/measure, /protocolSection/outcomesModule/secondaryOutcomes/4/measure, /protocolSection/outcomesModule/secondaryOutcomes/5/measure, /protocolSection/outcomesModule/secondaryOutcomes/6/measure, /protocolSection/outcomesModule/secondaryOutcomes/7/measure, /protocolSection/outcomesModule/otherOutcomes/0/measure, /protocolSection/outcomesModule/otherOutcomes/1/measure, /protocolSection/outcomesModule/otherOutcomes/2/measure, /protocolSection/outcomesModule/otherOutcomes/3/measure, /hasResults, /resultsSection, /annotationSection, /documentSection.",
    "An outcome path changed between versions 5 and 6 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
      "results_reconciliation"
    ],
    "category": "results_reconciliation",
    "deterministic_rules": [],
    "event_class_rule_set_hash": "07957f8b90549d4f42387f51b471ecde9901b6db63bbc27b84c73631603407c0",
    "event_classes": [
      "outcome_edit_cooccurs_with_results_posting"
    ],
    "rule_set_hash": "318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86",
    "severity": "low",
    "severity_pre_timing": "low",
    "timing_context": "late_recruitment",
    "triage_label": "low",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
    "value_signals": [
      {
        "category": "results_reconciliation",
        "paths": [
          "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
          "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
          "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
          "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/7/measure"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT03515798_v5_v6_0b625aa10e52",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2025-10"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2025-10-24"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2025-11-10"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstSubmitDate",
      "value": "2025-10-24"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
      "value": "Central Evaluation of Pathological Complete Response Rate"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
      "value": "end of study"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
      "value": {
        "resetReasons": [
          "Required information appears to be missing."
        ]
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
      "value": "Dose Limiting Toxicity (DLT) Rates"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
      "value": "Occurrence of Serious Adverse Events and Adverse Events Starting Grade 2 or Grade 1 (run-in Period)"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
      "value": "Local Evaluation of Pathological Complete Response Rate"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
      "value": "Invasive Disease-free Survival (IDFS)"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
      "value": "Invasive Disease-free Survival (IDFS)"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
      "value": "Event Free Survival (EFS)"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
      "value": "Event Free Survival (EFS)"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
      "value": "Overall Survival (OS)"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/7/measure",
      "value": "Overall Survival (OS)"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/otherOutcomes/0/measure",
      "value": "Evaluation of PD-L1 Expression in Pre, Per and Post-treatment Tissue"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/otherOutcomes/1/measure",
      "value": "Measurement of Baseline Circulating Tumor Cells for Prospective Validation of Their Prognostic Value in IBC"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/otherOutcomes/2/measure",
      "value": "Disease Monitoring"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/otherOutcomes/3/measure",
      "value": "Identification of Mechanisms of Treatment Resistance"
    },
    {
      "op": "replace",
      "path": "/hasResults",
      "value": true
    },
    {
      "op": "add",
      "path": "/resultsSection",
      "value": {
        "adverseEventsModule": {
          "description": "This study only recorded AEs related to the investigational product, unlike ClinicalTrials.gov\nwhich includes all events.\nAEs were collected via active surveillance from all treated participants during the treatment period.",
          "eventGroups": [
            {
              "deathsNumAffected": 0,
              "deathsNumAtRisk": 6,
              "description": "<p>EC Paclitaxel + Pembrolizumab Injection</p><p>Pembrolizumab Injection: Patients will receive intravenously 1 dose of Pembrolizumab every 3 weeks</p><p>neoadjuvant EC-paclitaxel chemotherapy: The cytotoxic regimen is a combination of dose-dense EC, followed by weekly paclitaxel</p>",
              "id": "EG000",
              "otherNumAffected": 6,
              "otherNumAtRisk": 6,
              "seriousNumAffected": 2,
              "seriousNumAtRisk": 6,
              "title": "Pembrolizumab"
            },
            {
              "deathsNumAffected": 0,
              "deathsNumAtRisk": 0,
              "description": "<p>EC Paclitaxel alone</p><p>neoadjuvant EC-paclitaxel chemotherapy: The cytotoxic regimen is a combination of dose-dense EC, followed by weekly paclitaxel</p>",
              "id": "EG001",
              "otherNumAffected": 0,
              "otherNumAtRisk": 0,
              "seriousNumAffected": 0,
              "seriousNumAtRisk": 0,
              "title": "Standard Neoadjuvant Chemotherapy"
            }
          ],
          "frequencyThreshold": "0",
          "otherEvents": [
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Blood and lymphatic system disorders",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 4,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "ANEMIA"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Endocrine disorders",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "HYPERTHYROIDISM"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "ASTHENIA"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "MUCOSAL INFLAMMATION"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 3,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "GAMMA-GLUTAMYLTRANSFERASE INCREASED"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 3,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "NEUTROPHIL COUNT DECREASED"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 3,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "WHITE BLOOD CELL COUNT DECREASED"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "HEADACHE"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 3,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "ALOPECIA"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "HYPERTENSION"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "CONSTIPATION"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 5,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "NAUSEA"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "FATIGUE"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Infections and infestations",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "URINARY TRACT INFECTION"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 3,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "LYMPHOCYTE COUNT DECREASED"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "GASTROINTESTINAL TOXICITY"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "PYREXIA"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "STOMATITIS"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "DIARRHEA"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "REFLUX GASTRITIS"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "BLOOD ALKALINE PHOSPHATASE INCREASED"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "HAEMATOCRIT DECREASED"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "NEUTROPHIL COUNT INCREASED"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "RASH"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Cardiac disorders",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "PALPITATIONS"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "ABDOMINAL PAIN"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "OEDEMA"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "WEIGHT GAIN"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Investigations",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "WEIGHT LOSS"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "notes": "ANOREXIA",
              "organSystem": "Metabolism and nutrition disorders",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "DECREASED APPETITE"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "DYSGEUSIA"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Nervous system disorders",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "PERIPHERAL SENSORY NEUROPATHY"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Psychiatric disorders",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "INSOMNIA"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "COUGH"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "stats": [
                {
                  "groupId": "EG000",
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                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
                  "numAffected": 0,
                  "numAtRisk": 0
                }
              ],
              "term": "ACNEA"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "notes": "BREAST ERYTHEMA",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "stats": [
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                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
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                }
              ],
              "term": "ERYTHEMA"
            },
            {
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                },
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              ],
              "term": "RASH MACULO-PAPULAR"
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              "organSystem": "Vascular disorders",
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                  "numAtRisk": 6
                },
                {
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                }
              ],
              "term": "HOT FLUSH"
            },
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              "organSystem": "Blood and lymphatic system disorders",
              "stats": [
                {
                  "groupId": "EG000",
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                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
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                  "numAtRisk": 0
                }
              ],
              "term": "FEBRILE NEUTROPENIA"
            },
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "notes": "LEUCOPENIA",
              "organSystem": "Blood and lymphatic system disorders",
              "stats": [
                {
                  "groupId": "EG000",
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                  "numAtRisk": 6
                },
                {
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                },
                {
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                  "numAffected": 0,
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              ],
              "term": "LYMPHOPENIA"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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              "organSystem": "Investigations",
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                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
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                  "numAtRisk": 0
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              ],
              "term": "BLOOD LACTATE DEHYDROGENASE INCREASED"
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              "assessmentType": "SYSTEMATIC_ASSESSMENT",
              "organSystem": "Metabolism and nutrition disorders",
              "stats": [
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                  "numAtRisk": 6
                },
                {
                  "groupId": "EG001",
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                  "numAtRisk": 0
                }
              ],
              "term": "HYPERKALAEMIA"
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          ],
          "reviewUnit": {
            "resetReasons": [
              "There does not appear to be sufficient information to understand the Time Frame."
            ]
          },
          "seriousEvents": [
            {
              "assessmentType": "SYSTEMATIC_ASSESSMENT",
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                },
                {
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              ],
              "term": "FEVER"
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            {
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                },
                {
                  "groupId": "EG001",
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                  "numAtRisk": 0
                }
              ],
              "term": "VOMITING"
            }
          ],
          "timeFrame": "from the time of treatment randomization through 30 days following cessation of study treat-ment"
        },
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            {
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              "description": "Total of all reporting groups",
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                  "categories": [
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                      "measurements": [
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                          "groupId": "BG000",
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                          "groupId": "BG002",
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                          "groupId": "BG000",
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                        {
                          "groupId": "BG002",
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                      ],
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                    {
                      "measurements": [
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                          "groupId": "BG000",
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                          "groupId": "BG002",
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                      ],
                      "units": "Participants"
                    }
                  ]
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "populationDescription": "Race and Ethnicity were not collected from any participant.",
              "title": "Race and Ethnicity Not Collected",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
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                      "units": "Participants"
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              "unitOfMeasure": "participants"
            }
          ],
          "popReviewUnit": {
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            ]
          },
          "populationDescription": "only pembrolizumab patients have been analyzed for DLT"
        },
        "moreInfoModule": {
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            "piSponsorEmployee": true
          },
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              "timeFrame": "during 21 days following the first administration of pembrolizumab",
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              "title": "Occurrence of Serious Adverse Events and Adverse Events Starting Grade 2 or Grade 1 (run-in Period)",
              "type": "SECONDARY"
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              "reportingStatus": "NOT_POSTED",
              "timeFrame": "Following completion of neoadjuvant systemic treatment, an average of 24 weeks",
              "title": "Local Evaluation of Pathological Complete Response Rate",
              "type": "SECONDARY"
            },
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              "denomUnitsSelected": "Participants",
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              "reportingStatus": "NOT_POSTED",
              "timeFrame": "3 years",
              "title": "Invasive Disease-free Survival (IDFS)",
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            },
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              "reportingStatus": "NOT_POSTED",
              "timeFrame": "5 years",
              "title": "Invasive Disease-free Survival (IDFS)",
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              "reportingStatus": "NOT_POSTED",
              "timeFrame": "3 years",
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              "timeFrame": "5 years",
              "title": "Event Free Survival (EFS)",
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            },
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            },
            {
              "denomUnitsSelected": "Participants",
              "description": "time from randomization to death from any cause",
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              "timeFrame": "5 years",
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            },
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              "denomUnitsSelected": "Participants",
              "description": "by IHC and mass spectrometry-based proteomics; and in plasma samples using quantitative proteomics,",
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              "reportingStatus": "NOT_POSTED",
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}