evt_NCT03735680_v8_v9_fd6b8a34ba8e

{
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    "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
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    "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
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    "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
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    "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
    "/hasResults",
    "/resultsSection",
    "/annotationSection",
    "/documentSection"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT03735680_v8_v9_fd6b8a34ba8e. ClinicalTrials.gov NCT03735680, versions 8-9. 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 8 to version 9 for NCT03735680.",
    "The JSON Patch for this comparison has hash 95bae5dbada909a7b719b96e6634ed4cd7883852d82102ecade982b9f659dd58.",
    "The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.",
    "The deterministic triage label was high; before timing adjustment it was high.",
    "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.",
    "A registry field under an arm or intervention module changed between ClinicalTrials.gov versions 8 and 9.",
    "The timing context for the from-version record was post_recruitment.",
    "The deterministic rules that fired were: arms_or_interventions_change.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/armsInterventionsModule/interventions/0/description, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit, /protocolSection/outcomesModule/primaryOutcomes/1/measure, /protocolSection/outcomesModule/primaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/2/measure, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /protocolSection/outcomesModule/secondaryOutcomes/3/measure, /protocolSection/outcomesModule/secondaryOutcomes/3/description, /protocolSection/outcomesModule/secondaryOutcomes/4/measure, /protocolSection/outcomesModule/secondaryOutcomes/4/description, /protocolSection/outcomesModule/secondaryOutcomes/5/measure, /protocolSection/outcomesModule/secondaryOutcomes/5/description, /hasResults, /resultsSection, /annotationSection, /documentSection.",
    "An outcome path changed between versions 8 and 9 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
  ],
  "classification": {
    "calibration_status": "uncalibrated",
    "categories": [
      "arm_intervention_change",
      "results_reconciliation"
    ],
    "category": "arm_intervention_change",
    "deterministic_rules": [
      "arms_or_interventions_change"
    ],
    "event_class_rule_set_hash": "74a6f55a686c29aa023171acd6b43f27ea95f2b0af2d49094ac70287ba4e502c",
    "event_classes": [
      "outcome_edit_cooccurs_with_results_posting"
    ],
    "rule_set_hash": "fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621",
    "severity": "high",
    "severity_pre_timing": "high",
    "timing_context": "post_recruitment",
    "triage_label": "high",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
    "value_signals": [
      {
        "category": "results_reconciliation",
        "paths": [
          "/protocolSection/outcomesModule/primaryOutcomes/0/description",
          "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
          "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
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          "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
          "/protocolSection/outcomesModule/secondaryOutcomes/5/measure"
        ],
        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
      }
    ]
  },
  "event_id": "evt_NCT03735680_v8_v9_fd6b8a34ba8e",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2023-01-16"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2023-02-13"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstSubmitDate",
      "value": "2023-01-16"
    },
    {
      "op": "replace",
      "path": "/protocolSection/armsInterventionsModule/interventions/0/description",
      "value": "A polymer micelle covalently conjugated to indocyanine green."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
      "value": "Measure Mean Fluorescence Intensity of Histologically Confirmed Tumor vs Normal Tissue in Patients Undergoing Routine Surgery [Tumor to Background Ratio (TBR)]"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
      "value": "<p>Part 1: Evaluate the dose(s) at which ONM-100 fluorescence imaging is feasible at 3±2 hours post dose.</p><p>Part 2: Verify the safety and diagnostic performance of ONM-100 compared to standard pathology at the dose(s) and imaging schedule(s) post dose selected from Part 1 for the detection of primary tumors and the metastatic lymph nodes in a variety of solid cancers (which could have included HNSCC, breast cancer, colorectal cancer, urothelial cancer, prostate cancer, ovarian cancer, and&#x2F;or non-small cell lung carcinoma [NSCLC]).</p><p>Part 3: Assess the safety and efficacy (sensitivity and positive predictive value [PPV] of ONM-100 for intraoperative imaging during HNSCC surgery.</p>"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
      "value": {
        "resetReasons": [
          "More than one baseline or outcome measure appears to be described, and it is unclear which measure the reported data represent."
        ]
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
      "value": "Incidence Rate of All Treatment-emergent Adverse Events (TEAEs) From Time of ONM-100 Administration Through Day 28"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/1/description",
      "value": "Evaluate safety at the dose(s) used to assess imaging feasibility and select the dose(s) and imaging schedule(s) post dose that are safe and provide optimal imaging of solid tumors and metastatic lymph nodes; the dose and time post dose chosen for the detection of primary tumors and metastatic lymph nodes could be the same or different."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
      "value": "Evaluate Pharmacokinetic Parameters: Cmax"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
      "value": "Evaluate the maximum plasma concentration (Cmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
      "value": "Evaluate Pharmacokinetic Parameters: Tmax"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
      "value": "Evaluate the time to Cmax (Tmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
      "value": "Evaluate Pharmacokinetic Parameters: AUC"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
      "value": "Evaluate the Area under the time-concentration curve [AUC] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
      "value": "Evaluate Pharmacokinetic Parameters: CL"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
      "value": "Evaluate Total body clearance [CL] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
      "value": "Evaluate Pharmacokinetic Parameters: Vz"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
      "value": "Evaluate the Volume of distribution [Vz] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
      "value": "Evaluate Pharmacokinetic Parameters: t1&#x2F;2"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
      "value": "Evaluate the Terminal elimination half-life [t1&#x2F;2] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2."
    },
    {
      "op": "replace",
      "path": "/hasResults",
      "value": true
    },
    {
      "op": "add",
      "path": "/resultsSection",
      "value": {
        "adverseEventsModule": {
          "armsReviewUnit": {
            "resetReasons": [
              "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
            ]
          },
          "eventGroups": [
            {
              "deathsNumAffected": 0,
              "deathsNumAtRisk": 30,
              "description": "<p>All patients in this arm will receive ONM-100 for injection and undergo intraoperative imaging.</p><p>ONM-100: A polymer micelle covalently conjugated to an ICG-like moiety.</p>",
              "id": "EG000",
              "otherNumAffected": 30,
              "otherNumAtRisk": 30,
              "seriousNumAffected": 6,
              "seriousNumAtRisk": 30,
              "title": "Patients Receiving ONM-100"
            }
          ],
          "frequencyThreshold": "0",
          "otherEvents": [
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 17,
                  "numAtRisk": 30,
                  "numEvents": 17
                }
              ],
              "term": "Infusion-related reaction"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 30,
                  "numEvents": 1
                }
              ],
              "term": "Buttock injury"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 30,
                  "numEvents": 1
                }
              ],
              "term": "Neck injury"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 30,
                  "numEvents": 1
                }
              ],
              "term": "Wound"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 30,
                  "numEvents": 2
                }
              ],
              "term": "Vomiting"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 30,
                  "numEvents": 1
                }
              ],
              "term": "Abdominal pain"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 30,
                  "numEvents": 1
                }
              ],
              "term": "Constipation"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 30,
                  "numEvents": 1
                }
              ],
              "term": "Diarrhea"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 30,
                  "numEvents": 1
                }
              ],
              "term": "Nausea"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Gastrointestinal disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 30,
                  "numEvents": 1
                }
              ],
              "term": "Oral pain"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 3,
                  "numAtRisk": 30,
                  "numEvents": 3
                }
              ],
              "term": "Neck pain"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 30,
                  "numEvents": 2
                }
              ],
              "term": "Myalgia"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 30,
                  "numEvents": 1
                }
              ],
              "term": "Arthralgia"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 30,
                  "numEvents": 1
                }
              ],
              "term": "Muscle spasms"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 30,
                  "numEvents": 1
                }
              ],
              "term": "Musculoskeletal stiffness"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Musculoskeletal and connective tissue disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 30,
                  "numEvents": 1
                }
              ],
              "term": "Pain in extremity"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 30,
                  "numEvents": 1
                }
              ],
              "term": "Fatigue"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 30,
                  "numEvents": 1
                }
              ],
              "term": "Injection site reaction"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 30,
                  "numEvents": 1
                }
              ],
              "term": "Malaise"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 30,
                  "numEvents": 1
                }
              ],
              "term": "Pain"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 30,
                  "numEvents": 1
                }
              ],
              "term": "Pyrexia"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 4,
                  "numAtRisk": 30,
                  "numEvents": 4
                }
              ],
              "term": "Nervous system disorders"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 30,
                  "numEvents": 2
                }
              ],
              "term": "Dizziness"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 30,
                  "numEvents": 2
                }
              ],
              "term": "Headache"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "General disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 30,
                  "numEvents": 1
                }
              ],
              "term": "Sensory disturbance"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 30,
                  "numEvents": 1
                }
              ],
              "term": "Procedural pain"
            }
          ],
          "seriousEvents": [
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 30,
                  "numEvents": 1
                }
              ],
              "term": "Cellulitis"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 30,
                  "numEvents": 1
                }
              ],
              "term": "Superficial Vein Thrombosis"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Skin and subcutaneous tissue disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 30,
                  "numEvents": 1
                }
              ],
              "term": "Abscess Neck"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Vascular disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 30,
                  "numEvents": 1
                }
              ],
              "term": "Thrombophlebitis"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Respiratory, thoracic and mediastinal disorders",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 1,
                  "numAtRisk": 30,
                  "numEvents": 1
                }
              ],
              "term": "Tonsillar Hemorrhage"
            },
            {
              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Injury, poisoning and procedural complications",
              "sourceVocabulary": "MedDRA (19.0)",
              "stats": [
                {
                  "groupId": "EG000",
                  "numAffected": 2,
                  "numAtRisk": 30,
                  "numEvents": 2
                }
              ],
              "term": "Infusion Related Reaction"
            }
          ],
          "timeFrame": "Adverse events were collected from the time of study drug administration throughout the course of the study. The total collection period for each subject was approximately one month."
        },
        "baselineCharacteristicsModule": {
          "denoms": [
            {
              "counts": [
                {
                  "groupId": "BG000",
                  "value": "30"
                }
              ],
              "units": "Participants"
            }
          ],
          "groups": [
            {
              "description": "<p>All patients in this arm will receive ONM-100 for injection and undergo intraoperative imaging.</p><p>ONM-100: A polymer micelle covalently conjugated to an ICG-like moiety.</p>",
              "id": "BG000",
              "title": "Patients Receiving ONM-100"
            }
          ],
          "measures": [
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "spread": "8.46",
                          "value": "60.5"
                        }
                      ]
                    }
                  ]
                }
              ],
              "dispersionType": "STANDARD_DEVIATION",
              "paramType": "MEAN",
              "title": "Age, Continuous",
              "unitOfMeasure": "years"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "8"
                        }
                      ],
                      "title": "Female"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "22"
                        }
                      ],
                      "title": "Male"
                    }
                  ]
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "title": "Sex: Female, Male",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "3"
                        }
                      ],
                      "title": "Hispanic or Latino"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "25"
                        }
                      ],
                      "title": "Not Hispanic or Latino"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "2"
                        }
                      ],
                      "title": "Unknown or Not Reported"
                    }
                  ]
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "title": "Ethnicity (NIH&#x2F;OMB)",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        }
                      ],
                      "title": "American Indian or Alaska Native"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "1"
                        }
                      ],
                      "title": "Asian"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        }
                      ],
                      "title": "Native Hawaiian or Other Pacific Islander"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "5"
                        }
                      ],
                      "title": "Black or African American"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "22"
                        }
                      ],
                      "title": "White"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        }
                      ],
                      "title": "More than one race"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "2"
                        }
                      ],
                      "title": "Unknown or Not Reported"
                    }
                  ]
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "title": "Race (NIH&#x2F;OMB)",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "30"
                        }
                      ]
                    }
                  ],
                  "title": "United States"
                }
              ],
              "paramType": "NUMBER",
              "title": "Region of Enrollment",
              "unitOfMeasure": "participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "30"
                        }
                      ]
                    }
                  ]
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "title": "Patients receiving ONM-100",
              "unitOfMeasure": "Participants"
            }
          ],
          "reviewUnit": {
            "resetReasons": [
              "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
            ]
          }
        },
        "moreInfoModule": {
          "certainAgreement": {
            "piSponsorEmployee": false,
            "restrictiveAgreement": false
          },
          "pointOfContact": {
            "email": "clinicaltrials@onconanomed.com",
            "organization": "OncoNano Medicine, Inc.",
            "phone": "682-285-1411",
            "title": "Vice President, Clinical Operations"
          }
        },
        "outcomeMeasuresModule": {
          "outcomeMeasures": [
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "2.2128",
                          "value": "2.858"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "1.3717",
                          "value": "3.498"
                        },
                        {
                          "groupId": "OG002",
                          "spread": "2.5936",
                          "value": "2.608"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "3"
                    },
                    {
                      "groupId": "OG001",
                      "value": "3"
                    },
                    {
                      "groupId": "OG002",
                      "value": "2"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "<p>Part 1: Evaluate the dose(s) at which ONM-100 fluorescence imaging is feasible at 3±2 hours post dose.</p><p>Part 2: Verify the safety and diagnostic performance of ONM-100 compared to standard pathology at the dose(s) and imaging schedule(s) post dose selected from Part 1 for the detection of primary tumors and the metastatic lymph nodes in a variety of solid cancers (which could have included HNSCC, breast cancer, colorectal cancer, urothelial cancer, prostate cancer, ovarian cancer, and&#x2F;or non-small cell lung carcinoma [NSCLC]).</p><p>Part 3: Assess the safety and efficacy (sensitivity and positive predictive value [PPV] of ONM-100 for intraoperative imaging during HNSCC surgery.</p>",
              "dispersionType": "Standard Deviation",
              "groups": [
                {
                  "description": "All patients in this arm received a single IV administration of ONM-100 at 1 mg&#x2F;kg.",
                  "id": "OG000",
                  "title": "ONM-100 at a Dose of 1 mg&#x2F;kg"
                },
                {
                  "description": "All patients in this arm received a single IV administration of ONM-100 at 3 mg&#x2F;kg.",
                  "id": "OG001",
                  "title": "ONM-100 at a Dose of 3 mg&#x2F;kg"
                },
                {
                  "description": "All patients in this arm received a single IV administration of ONM-100 at 2 mg&#x2F;kg.",
                  "id": "OG002",
                  "title": "ONM-100 at a Dose of 2 mg&#x2F;kg"
                }
              ],
              "measureCategoriesReviewUnit": {
                "resetReasons": [
                  "The Unit of Measure appears inconsistent with the Measure Title, the Measure Description, or both."
                ]
              },
              "paramType": "MEAN",
              "reportingStatus": "POSTED",
              "reviewUnit": {
                "resetReasons": [
                  "More than one baseline or outcome measure appears to be described, and it is unclear which measure the reported data represent."
                ]
              },
              "timeFrame": "1 day",
              "title": "Measure Mean Fluorescence Intensity of Histologically Confirmed Tumor vs Normal Tissue in Patients Undergoing Routine Surgery [Tumor to Background Ratio (TBR)]",
              "type": "PRIMARY",
              "unitOfMeasure": "units on a scale"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "value": "26"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "30"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Evaluate safety at the dose(s) used to assess imaging feasibility and select the dose(s) and imaging schedule(s) post dose that are safe and provide optimal imaging of solid tumors and metastatic lymph nodes; the dose and time post dose chosen for the detection of primary tumors and metastatic lymph nodes could be the same or different.",
              "groups": [
                {
                  "description": "<p>All patients in this arm will receive ONM-100 for injection and undergo intraoperative imaging.</p><p>ONM-100: A polymer micelle covalently conjugated to IGC.</p>",
                  "id": "OG000",
                  "title": "Patients Receiving ONM-100"
                }
              ],
              "measureCategoriesReviewUnit": {
                "resetReasons": [
                  "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
                ]
              },
              "paramType": "COUNT_OF_PARTICIPANTS",
              "reportingStatus": "POSTED",
              "timeFrame": "28 days",
              "title": "Incidence Rate of All Treatment-emergent Adverse Events (TEAEs) From Time of ONM-100 Administration Through Day 28",
              "type": "PRIMARY",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "16.0",
                          "value": "26.5"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "13.0",
                          "value": "52.2"
                        },
                        {
                          "groupId": "OG002",
                          "spread": "30.0",
                          "value": "79.5"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "9"
                    },
                    {
                      "groupId": "OG001",
                      "value": "4"
                    },
                    {
                      "groupId": "OG002",
                      "value": "6"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Evaluate the maximum plasma concentration (Cmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.",
              "dispersionType": "Geometric Coefficient of Variation",
              "groups": [
                {
                  "description": "All patients in this arm received a single IV administration of ONM-100 at 1 mg&#x2F;kg.",
                  "id": "OG000",
                  "title": "ONM-100 at a Dose of 1 mg&#x2F;kg"
                },
                {
                  "description": "All patients in this arm received a single IV administration of ONM-100 at 2 mg&#x2F;kg.",
                  "id": "OG001",
                  "title": "ONM-100 at a Dose of 2 mg&#x2F;kg"
                },
                {
                  "description": "All patients in this arm received a single IV administration of ONM-100 at 3 mg&#x2F;kg.",
                  "id": "OG002",
                  "title": "ONM-100 at a Dose of 3 mg&#x2F;kg"
                }
              ],
              "paramType": "GEOMETRIC_MEAN",
              "populationDescription": "The PK analysis population is comprised 19 patients for whom concentration data were available.\nDue to sparse plasma concentrations for the majority of patients, with the exception of Cmax and Tmax, it was not possible to estimate all parameters for all patients.",
              "reportingStatus": "POSTED",
              "timeFrame": "6 days",
              "title": "Evaluate Pharmacokinetic Parameters: Cmax",
              "type": "SECONDARY",
              "unitOfMeasure": "μg&#x2F;mL"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "lowerLimit": "0.22",
                          "upperLimit": "1.12",
                          "value": "0.25"
                        },
                        {
                          "groupId": "OG001",
                          "lowerLimit": "0.27",
                          "upperLimit": "7.35",
                          "value": "0.31"
                        },
                        {
                          "groupId": "OG002",
                          "lowerLimit": "0.23",
                          "upperLimit": "0.37",
                          "value": "0.31"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "9"
                    },
                    {
                      "groupId": "OG001",
                      "value": "4"
                    },
                    {
                      "groupId": "OG002",
                      "value": "6"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Evaluate the time to Cmax (Tmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.",
              "dispersionType": "Full Range",
              "groups": [
                {
                  "description": "All patients in this arm received IV administration of ONM-100 at a dose of 1 mg&#x2F;kg.",
                  "id": "OG000",
                  "title": "ONM-100 at Dose of 1 mg&#x2F;kg"
                },
                {
                  "description": "All patients in this arm received IV administration of ONM-100 at a dose of 2 mg&#x2F;kg.",
                  "id": "OG001",
                  "title": "ONM-100 at a Dose of 2 mg&#x2F;kg"
                },
                {
                  "description": "All patients in this arm received IV administration of ONM-100 at a dose of 3 mg&#x2F;kg.",
                  "id": "OG002",
                  "title": "ONM-100 at a Dose of 3 mg&#x2F;kg"
                }
              ],
              "paramType": "MEDIAN",
              "populationDescription": "The PK analysis population comprised 19 patients for whom concentration data were available.\nDue to sparse plasma concentrations for the majority of patients, with the exception of Cmax and Tmax, it was not possible to estimate all parameters for all patients.",
              "reportingStatus": "POSTED",
              "timeFrame": "6 days",
              "title": "Evaluate Pharmacokinetic Parameters: Tmax",
              "type": "SECONDARY",
              "unitOfMeasure": "hr"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "127",
                          "value": "433"
                        },
                        {
                          "groupId": "OG001",
                          "spread": "80.1",
                          "value": "1509"
                        },
                        {
                          "groupId": "OG002",
                          "spread": "38.4",
                          "value": "2067"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "9"
                    },
                    {
                      "groupId": "OG001",
                      "value": "3"
                    },
                    {
                      "groupId": "OG002",
                      "value": "6"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Evaluate the Area under the time-concentration curve [AUC] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.",
              "dispersionType": "Geometric Coefficient of Variation",
              "groups": [
                {
                  "description": "Patients receiving a single IV administration of ONM-100 at 1 mg&#x2F;kg.",
                  "id": "OG000",
                  "title": "ONM-100 at a Dose of 1 mg&#x2F;kg"
                },
                {
                  "description": "Patients received a single IV administration of ONM-100 at 2 mg&#x2F;kg.",
                  "id": "OG001",
                  "title": "ONM-100 at a Dose of 2 mg&#x2F;kg"
                },
                {
                  "description": "Patients receiving a single IV administration of ONM-100 at 3 mg&#x2F;kg.",
                  "id": "OG002",
                  "title": "ONM-100 at a Dose of 3 mg&#x2F;kg"
                }
              ],
              "paramType": "GEOMETRIC_MEAN",
              "populationDescription": "The PK analysis population comprised 19 patients for whom concentration data were available.\nDue to sparse plasma concentrations for the majority of patients, with the exception of Cmax and Tmax, it was not possible to estimate all parameters for all patients.",
              "reportingStatus": "POSTED",
              "timeFrame": "6 days",
              "title": "Evaluate Pharmacokinetic Parameters: AUC",
              "type": "SECONDARY",
              "unitOfMeasure": "hr x μg&#x2F;mL"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "2.57",
                          "value": "0.053"
                        },
                        {
                          "groupId": "OG002",
                          "spread": "70.5",
                          "value": "0.053"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "2"
                    },
                    {
                      "groupId": "OG001",
                      "value": "0"
                    },
                    {
                      "groupId": "OG002",
                      "value": "2"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Evaluate Total body clearance [CL] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.",
              "dispersionType": "Geometric Coefficient of Variation",
              "groups": [
                {
                  "description": "Patients receiving a single IV administration of ONM-100 at 1 mg&#x2F;kg.",
                  "id": "OG000",
                  "title": "ONM-100 at a Dose of 1 mg&#x2F;kg"
                },
                {
                  "description": "Patients received a single IV administration of ONM-100 at 2 mg&#x2F;kg.",
                  "id": "OG001",
                  "title": "ONM-100 at a Dose of 2 mg&#x2F;kg"
                },
                {
                  "description": "Patients receiving a single IV administration of ONM-100 at 3 mg&#x2F;kg.",
                  "id": "OG002",
                  "title": "ONM-100 at a Dose of 3 mg&#x2F;kg"
                }
              ],
              "paramType": "GEOMETRIC_MEAN",
              "populationDescription": "The PK analysis population comprised 19 patients for whom concentration data were available.\nDue to the sparse plasma concentrations for the majority of patients, with the exception of Cmax and Tmax, it was not possible to estimate all parameters for all patients.",
              "reportingStatus": "POSTED",
              "timeFrame": "6 days",
              "title": "Evaluate Pharmacokinetic Parameters: CL",
              "type": "SECONDARY",
              "unitOfMeasure": "L&#x2F;hr"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "33.9",
                          "value": "3.78"
                        },
                        {
                          "groupId": "OG002",
                          "spread": "82.9",
                          "value": "5.32"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "2"
                    },
                    {
                      "groupId": "OG001",
                      "value": "0"
                    },
                    {
                      "groupId": "OG002",
                      "value": "2"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Evaluate the Volume of distribution [Vz] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.",
              "dispersionType": "Geometric Coefficient of Variation",
              "groups": [
                {
                  "description": "All patients in this arm received IV administration of ONM-100 at a dose of 1 mg&#x2F;kg.",
                  "id": "OG000",
                  "title": "ONM-100 at Dose of 1 mg&#x2F;kg"
                },
                {
                  "description": "All patients in this arm received IV administration of ONM-100 at a dose of 2 mg&#x2F;kg.",
                  "id": "OG001",
                  "title": "ONM-100 at a Dose of 2 mg&#x2F;kg"
                },
                {
                  "description": "All patients in this arm received IV administration of ONM-100 at a dose of 3 mg&#x2F;kg.",
                  "id": "OG002",
                  "title": "ONM-100 at a Dose of 3 mg&#x2F;kg"
                }
              ],
              "paramType": "GEOMETRIC_MEAN",
              "populationDescription": "The PK analysis population comprised 19 patients for whom concentration data were available.\nDue to sparse plasma concentrations for the majority of patients, with the exception of Cmax and Tmax, it was not possible to estimate all parameters for all patients.",
              "reportingStatus": "POSTED",
              "timeFrame": "6 days",
              "title": "Evaluate Pharmacokinetic Parameters: Vz",
              "type": "SECONDARY",
              "unitOfMeasure": "L"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "OG000",
                          "spread": "36.7",
                          "value": "49.0"
                        },
                        {
                          "groupId": "OG002",
                          "spread": "8.80",
                          "value": "69.4"
                        }
                      ]
                    }
                  ]
                }
              ],
              "denoms": [
                {
                  "counts": [
                    {
                      "groupId": "OG000",
                      "value": "2"
                    },
                    {
                      "groupId": "OG001",
                      "value": "0"
                    },
                    {
                      "groupId": "OG002",
                      "value": "2"
                    }
                  ],
                  "units": "Participants"
                }
              ],
              "description": "Evaluate the Terminal elimination half-life [t1&#x2F;2] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2.",
              "dispersionType": "Geometric Coefficient of Variation",
              "groups": [
                {
                  "description": "All patients in this arm received IV administration of ONM-100 at a dose of 1 mg&#x2F;kg.",
                  "id": "OG000",
                  "title": "ONM-100 at Dose of 1 mg&#x2F;kg"
                },
                {
                  "description": "All patients in this arm received IV administration of ONM-100 at a dose of 2 mg&#x2F;kg.",
                  "id": "OG001",
                  "title": "ONM-100 at a Dose of 2 mg&#x2F;kg"
                },
                {
                  "description": "All patients in this arm received IV administration of ONM-100 at a dose of 3 mg&#x2F;kg.",
                  "id": "OG002",
                  "title": "ONM-100 at a Dose of 3 mg&#x2F;kg"
                }
              ],
              "paramType": "GEOMETRIC_MEAN",
              "populationDescription": "The PK analysis population comprised 19 patients for whom concentration data were available.\nDue to the sparse plasma concentrations for the majority of patients, with the exception of Cmax and Tmax, it was not possible to estimate all parameters for all patients.",
              "reportingStatus": "POSTED",
              "timeFrame": "6 days",
              "title": "Evaluate Pharmacokinetic Parameters: t1&#x2F;2",
              "type": "SECONDARY",
              "unitOfMeasure": "hr"
            }
          ]
        },
        "participantFlowModule": {
          "groups": [
            {
              "description": "<p>All patients in this arm will receive ONM-100 for injection and undergo intraoperative imaging.</p><p>ONM-100: A polymer micelle covalently conjugated to IGC.</p>",
              "id": "FG000",
              "title": "Patients Receiving ONM-100"
            }
          ],
          "periods": [
            {
              "dropWithdraws": [
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "1"
                    }
                  ],
                  "type": "Withdrawal by Subject"
                },
                {
                  "reasons": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "2"
                    }
                  ],
                  "type": "Patient unable or unwilling to continue"
                }
              ],
              "milestones": [
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "30"
                    }
                  ],
                  "type": "STARTED"
                },
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "27"
                    }
                  ],
                  "type": "COMPLETED"
                },
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "3"
                    }
                  ],
                  "type": "NOT COMPLETED"
                }
              ],
              "title": "Overall Study"
            }
          ],
          "reviewUnit": {
            "resetReasons": [
              "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
            ]
          }
        }
      }
    },
    {
      "op": "add",
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