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Evidence Record

evt_NCT03152929_v1_v2_71a6c52c5537

NCT03152929 · Paravertebral Block (PVC) Versus Pectoral Nerve Block (PEC)

Superseded Evidence Record

This page preserves the immutable v0.1.2 record. Its current successor is evt_NCT03152929_v1_v2_1bc7236fb8b2.

Severity is deterministic, reproducible, uncalibrated triage metadata, not validated review priority or proven wrongdoing. This page states what the registry evidence supports and what it does not support.
Triage severity
Triage: Low
Category
Results Reconciliation
Versions
v1 to v2
Timing
Post Recruitment

Claims Supported

  • TrialDiff compared ClinicalTrials.gov record version 1 to version 2 for NCT03152929.
  • The JSON Patch for this comparison has hash 0b62abbde3f4a428949d1698007f928e07ab90e663449b34a5e90f0a8881de95.
  • 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 post_recruitment.
  • The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit, /protocolSection/outcomesModule/primaryOutcomes/1/measure, /protocolSection/outcomesModule/primaryOutcomes/1/description, /protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit, /protocolSection/outcomesModule/primaryOutcomes/2/measure, /protocolSection/outcomesModule/primaryOutcomes/2/description, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit, /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, /protocolSection/contactsLocationsModule/locations/0/facility, /hasResults, /resultsSection, /annotationSection, /documentSection.
  • An outcome path changed between versions 1 and 2 in a patch that also carried a hasResults or resultsSection co-occurrence signal.

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.

Neutral Review Question

What source document explains this registry amendment, and does it change interpretation of the trial record?

Citation

TrialDiff Evidence Record evt_NCT03152929_v1_v2_71a6c52c5537. ClinicalTrials.gov NCT03152929, versions 1-2. Evidence version 1.

Event Classes

outcome_edit_cooccurs_with_results_posting

Changed Paths

/protocolSection/statusModule/statusVerifiedDate
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/resultsFirstSubmitDate
/protocolSection/outcomesModule/primaryOutcomes/0/description
/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit
/protocolSection/outcomesModule/primaryOutcomes/1/measure
/protocolSection/outcomesModule/primaryOutcomes/1/description
/protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit
/protocolSection/outcomesModule/primaryOutcomes/2/measure
/protocolSection/outcomesModule/primaryOutcomes/2/description
/protocolSection/outcomesModule/secondaryOutcomes/0/measure
/protocolSection/outcomesModule/secondaryOutcomes/0/reviewUnit
/protocolSection/outcomesModule/secondaryOutcomes/1/measure
/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit
/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
/protocolSection/contactsLocationsModule/locations/0/facility
/hasResults
/resultsSection
/annotationSection
/documentSection

View the field-level diff for before/after values on each changed path.

Deterministic Rules

No deterministic rules recorded.

Provenance

Package generation
v0.1.2
Succeeded by
evt_NCT03152929_v1_v2_1bc7236fb8b2
Patch hash
0b62abbde3f4a428949d1698007f928e07ab90e663449b34a5e90f0a8881de95
Canonical hash
2d1b094cd709b5d3bf1b9cae959e23a9e1a18de47811d428caef5c728fd5c897
Rule set hash
318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86
From snapshot
2ced69127508c6c8ead70f79259826564553712e529903b648b0c060489af183
To snapshot
277c1d27b1ed7ff1058fe9e4c9a91b2c6e1e50a38f60971f6b1cc2813f8e29ff
Patch source
ctgov_internal_history
Generated at
2026-07-31T00:42:12.000Z
Source URL
Registry payload

Canonical JSON Preview

Stored payload
{
  "changed_paths": [
    "/protocolSection/statusModule/statusVerifiedDate",
    "/protocolSection/statusModule/lastUpdateSubmitDate",
    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "/protocolSection/statusModule/resultsFirstSubmitDate",
    "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
    "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
    "/protocolSection/outcomesModule/primaryOutcomes/1/description",
    "/protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit",
    "/protocolSection/outcomesModule/primaryOutcomes/2/measure",
    "/protocolSection/outcomesModule/primaryOutcomes/2/description",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/0/reviewUnit",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
    "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
    "/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",
    "/protocolSection/contactsLocationsModule/locations/0/facility",
    "/hasResults",
    "/resultsSection",
    "/annotationSection",
    "/documentSection"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT03152929_v1_v2_71a6c52c5537. ClinicalTrials.gov NCT03152929, versions 1-2. 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 1 to version 2 for NCT03152929.",
    "The JSON Patch for this comparison has hash 0b62abbde3f4a428949d1698007f928e07ab90e663449b34a5e90f0a8881de95.",
    "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 post_recruitment.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit, /protocolSection/outcomesModule/primaryOutcomes/1/measure, /protocolSection/outcomesModule/primaryOutcomes/1/description, /protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit, /protocolSection/outcomesModule/primaryOutcomes/2/measure, /protocolSection/outcomesModule/primaryOutcomes/2/description, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit, /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, /protocolSection/contactsLocationsModule/locations/0/facility, /hasResults, /resultsSection, /annotationSection, /documentSection.",
    "An outcome path changed between versions 1 and 2 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": "post_recruitment",
    "triage_label": "low",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
    "value_signals": [
      {
        "category": "results_reconciliation",
        "paths": [
          "/protocolSection/outcomesModule/primaryOutcomes/0/description",
          "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
          "/protocolSection/outcomesModule/primaryOutcomes/1/description",
          "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
          "/protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit",
          "/protocolSection/outcomesModule/primaryOutcomes/2/description",
          "/protocolSection/outcomesModule/primaryOutcomes/2/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/0/reviewUnit",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
          "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
          "/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_NCT03152929_v1_v2_71a6c52c5537",
  "evidence_version": 1,
  "patch": [
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2023-03"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2023-03-30"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2023-04-21"
    },
    {
      "op": "add",
      "path": "/protocolSection/statusModule/resultsFirstSubmitDate",
      "value": "2023-03-30"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
      "value": "Participants for whom Narcotics were used for pain during surgery"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
      "value": {
        "resetReasons": [
          "The Time Frame appears inconsistent with information provided here or in other parts of the record."
        ]
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
      "value": "Post Anesthesia Care Unit (PACU) Narcotic Use"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/1/description",
      "value": "Participants for whom Narcotics were used in PACU"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit",
      "value": {
        "resetReasons": [
          "The Time Frame appears inconsistent with information provided here or in other parts of the record."
        ]
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/2/measure",
      "value": "Postoperative Narcotic Use"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/2/description",
      "value": "Participants for whom Narcotics were used postoperatively"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
      "value": "Pain Control Measured by Length of Operation"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/reviewUnit",
      "value": {
        "resetReasons": [
          "The Time Frame appears inconsistent with information provided here or in other parts of the record."
        ]
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
      "value": "Pain Control Measured by Estimated Blood Loss"
    },
    {
      "op": "add",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
      "value": {
        "resetReasons": [
          "The Time Frame appears inconsistent with information provided here or in other parts of the record."
        ]
      }
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
      "value": "Participants With Postoperative Nausea"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
      "value": "count of participants who reported nausea after surgery"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
      "value": "Pain Control Measured by Pain Scale"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
      "value": "Pain measured on scale of one to ten, one being least amount of pain and ten the greatest."
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
      "value": "Pain Control Measured by the Use of Pain Pills Postoperatively"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
      "value": "Participants who used narcotic pain pills postoperatively"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
      "value": "Pain Control Measured by Calls to Physicians Office Relating to Pain"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
      "value": "Number of phone calls made to physician office regarding pain"
    },
    {
      "op": "replace",
      "path": "/protocolSection/contactsLocationsModule/locations/0/facility",
      "value": "Esther L Peariso"
    },
    {
      "op": "replace",
      "path": "/hasResults",
      "value": true
    },
    {
      "op": "add",
      "path": "/resultsSection",
      "value": {
        "adverseEventsModule": {
          "description": "pain was not considered an adverse event unless it reached a grade 3 by CTCAE v4.0",
          "eventGroups": [
            {
              "deathsNumAffected": 0,
              "deathsNumAtRisk": 40,
              "description": "<p>The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Paravertebral Block: 20-30 mL 0.5% Ropivacaine</p>",
              "id": "EG000",
              "otherNumAffected": 0,
              "otherNumAtRisk": 40,
              "seriousNumAffected": 0,
              "seriousNumAtRisk": 40,
              "title": "Paravertebral Block"
            },
            {
              "deathsNumAffected": 0,
              "deathsNumAtRisk": 49,
              "description": "<p>The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine</p>",
              "id": "EG001",
              "otherNumAffected": 0,
              "otherNumAtRisk": 49,
              "seriousNumAffected": 0,
              "seriousNumAtRisk": 49,
              "title": "Pectoral Nerve Block"
            }
          ],
          "frequencyThreshold": "5",
          "timeFrame": "Adverse events were collected from the time of surgery until the 2 week post op appointment"
        },
        "baselineCharacteristicsModule": {
          "denoms": [
            {
              "counts": [
                {
                  "groupId": "BG000",
                  "value": "40"
                },
                {
                  "groupId": "BG001",
                  "value": "49"
                },
                {
                  "groupId": "BG002",
                  "value": "89"
                }
              ],
              "units": "Participants"
            }
          ],
          "groups": [
            {
              "description": "<p>The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Paravertebral Block: 20-30 mL 0.5% Ropivacaine</p>",
              "id": "BG000",
              "title": "Paravertebral Block"
            },
            {
              "description": "<p>The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)</p><p>Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine</p>",
              "id": "BG001",
              "title": "Pectoral Nerve Block"
            },
            {
              "description": "Total of all reporting groups",
              "id": "BG002",
              "title": "Total"
            }
          ],
          "measures": [
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "spread": "10.18",
                          "value": "65.15"
                        },
                        {
                          "groupId": "BG001",
                          "spread": "11.42",
                          "value": "64.24"
                        },
                        {
                          "groupId": "BG002",
                          "spread": "10.83",
                          "value": "64.65"
                        }
                      ]
                    }
                  ]
                }
              ],
              "dispersionType": "STANDARD_DEVIATION",
              "paramType": "MEAN",
              "title": "Age, Continuous",
              "unitOfMeasure": "years"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "40"
                        },
                        {
                          "groupId": "BG001",
                          "value": "49"
                        },
                        {
                          "groupId": "BG002",
                          "value": "89"
                        }
                      ],
                      "title": "Female"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        }
                      ],
                      "title": "Male"
                    }
                  ]
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "title": "Sex: Female, Male",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        }
                      ],
                      "title": "American Indian or Alaska Native"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        }
                      ],
                      "title": "Asian"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        }
                      ],
                      "title": "Native Hawaiian or Other Pacific Islander"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "1"
                        },
                        {
                          "groupId": "BG001",
                          "value": "1"
                        },
                        {
                          "groupId": "BG002",
                          "value": "2"
                        }
                      ],
                      "title": "Black or African American"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "39"
                        },
                        {
                          "groupId": "BG001",
                          "value": "48"
                        },
                        {
                          "groupId": "BG002",
                          "value": "87"
                        }
                      ],
                      "title": "White"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        }
                      ],
                      "title": "More than one race"
                    },
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "0"
                        },
                        {
                          "groupId": "BG001",
                          "value": "0"
                        },
                        {
                          "groupId": "BG002",
                          "value": "0"
                        }
                      ],
                      "title": "Unknown or Not Reported"
                    }
                  ]
                }
              ],
              "paramType": "COUNT_OF_PARTICIPANTS",
              "title": "Race (NIH&#x2F;OMB)",
              "unitOfMeasure": "Participants"
            },
            {
              "classes": [
                {
                  "categories": [
                    {
                      "measurements": [
                        {
                          "groupId": "BG000",
                          "value": "40"
                        },
                        {
                          "groupId": "BG001",
                          "value": "49"
                        },
                        {
                          "groupId": "BG002",
                          "value": "89"
                        }
                      ]
                    }
                  ],
                  "title": "United States"
                }
              ],
              "paramType": "NUMBER",
              "title": "Region of Enrollment",
              "unitOfMeasure": "participants"
            }
          ]
        },
        "moreInfoModule": {
          "certainAgreement": {
            "piSponsorEmployee": true
          },
          "limitationsAndCaveats": {
            "description": "Study was terminated early due to clinical practice outpacing the science of the trial.\nAt the time of stopping enrollment, pectoral nerve blocks were being used standardly.\nTherefore, we could not ethically continue to randomize patients to both arms."
          },
          "pointOfContact": {
            "email": "marianne.melnik@corewellhealth.org",
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