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Evidence Record

evt_NCT03735680_v9_v10_c37a64465442

NCT03735680 · A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer

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: High
Category
Serious Adverse Event Modification
Versions
v9 to v10
Timing
Post Recruitment

Claims Supported

  • TrialDiff compared ClinicalTrials.gov record version 9 to version 10 for NCT03735680.
  • The JSON Patch for this comparison has hash 07493602bef2c37bc1fd6d8f599b2b18834c10d5111091aa0d43d13bbba7858b.
  • 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 path under serious adverse event results changed between ClinicalTrials.gov versions 9 and 10.
  • The timing context for the from-version record was post_recruitment.
  • The deterministic rules that fired were: adverse_event_group_change, serious_adverse_event_modification.
  • The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /resultsSection/participantFlowModule/groups/0/title, /resultsSection/participantFlowModule/groups/0/description, /resultsSection/participantFlowModule/groups/1, /resultsSection/participantFlowModule/groups/2, /resultsSection/participantFlowModule/groups/3, /resultsSection/participantFlowModule/groups/4, /resultsSection/participantFlowModule/groups/5, /resultsSection/participantFlowModule/periods/0/milestones/0/achievements/0/numSubjects, /resultsSection/participantFlowModule/periods/0/milestones/0/achievements/1, /resultsSection/participantFlowModule/periods/0/milestones/0/achievements/2, /resultsSection/participantFlowModule/periods/0/milestones/0/achievements/3, /resultsSection/participantFlowModule/periods/0/milestones/0/achievements/4, /resultsSection/participantFlowModule/periods/0/milestones/0/achievements/5, /resultsSection/participantFlowModule/periods/0/milestones/1/achievements/0/numSubjects, /resultsSection/participantFlowModule/periods/0/milestones/1/achievements/1, /resultsSection/participantFlowModule/periods/0/milestones/1/achievements/2, /resultsSection/participantFlowModule/periods/0/milestones/1/achievements/3, /resultsSection/participantFlowModule/periods/0/milestones/1/achievements/4, /resultsSection/participantFlowModule/periods/0/milestones/1/achievements/5, /resultsSection/participantFlowModule/periods/0/milestones/2/achievements/0/numSubjects, /resultsSection/participantFlowModule/periods/0/milestones/2/achievements/1, /resultsSection/participantFlowModule/periods/0/milestones/2/achievements/2, /resultsSection/participantFlowModule/periods/0/milestones/2/achievements/3, /resultsSection/participantFlowModule/periods/0/milestones/2/achievements/4, /resultsSection/participantFlowModule/periods/0/milestones/2/achievements/5, /resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/0/numSubjects, /resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/1, /resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/2, /resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/3, /resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/4, /resultsSection/participantFlowModule/periods/0/dropWithdraws/0/reasons/5, /resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/0/numSubjects, /resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/1, /resultsSection/participantFlowModule/periods/0/dropWithdraws/1/reasons/2, 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/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/3, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/4, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/5, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/0/value, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/1, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/2, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/3, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/4, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/5, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/0/value, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/1, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/2, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/3, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/4, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/5, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/0/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/0/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/1/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/1/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/2/title, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/2/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/measureCategoriesReviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/description, /resultsSection/adverseEventsModule/timeFrame, /resultsSection/adverseEventsModule/eventGroups/0/description, /resultsSection/adverseEventsModule/eventGroups/0/deathsNumAtRisk, /resultsSection/adverseEventsModule/eventGroups/0/otherNumAffected, /resultsSection/adverseEventsModule/seriousEvents/0/organSystem, /resultsSection/adverseEventsModule/seriousEvents/0/assessmentType, /resultsSection/adverseEventsModule/seriousEvents/1/term, /resultsSection/adverseEventsModule/seriousEvents/1/organSystem, /resultsSection/adverseEventsModule/seriousEvents/2/term, /resultsSection/adverseEventsModule/seriousEvents/2/organSystem, /resultsSection/adverseEventsModule/seriousEvents/4/term, /resultsSection/adverseEventsModule/seriousEvents/4/organSystem, /resultsSection/adverseEventsModule/seriousEvents/5/term, /resultsSection/adverseEventsModule/description, /resultsSection/adverseEventsModule/reviewUnit, /resultsSection/adverseEventsModule/allCauseMortalityReviewUnit, /annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date, /reviewUnit.
  • An outcome path changed between versions 9 and 10 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 the modified serious adverse event results record?

Citation

TrialDiff Evidence Record evt_NCT03735680_v9_v10_c37a64465442. ClinicalTrials.gov NCT03735680, versions 9-10. Evidence version 1.

Event Classes

outcome_edit_cooccurs_with_results_posting

Changed Paths

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/resultsSection/adverseEventsModule/timeFrame
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/resultsSection/adverseEventsModule/seriousEvents/0/assessmentType
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/resultsSection/adverseEventsModule/seriousEvents/2/term
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/resultsSection/adverseEventsModule/allCauseMortalityReviewUnit
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/reviewUnit

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

Deterministic Rules

adverse_event_group_changeserious_adverse_event_modification

Provenance

Package generation
v0.1.3 (active)
Supersedes
evt_NCT03735680_v9_v10_ee0c9fe52d7a
Patch hash
07493602bef2c37bc1fd6d8f599b2b18834c10d5111091aa0d43d13bbba7858b
Canonical hash
9aed92693d28fc048087174f6ca23cd885d87888afb67a053e0a932c23761798
Rule set hash
fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621
From snapshot
84e2c2cc603b91a9f29ecd6bafd847dbf3da0a7a5bf788ff1a134934d20dd923
To snapshot
19d6665a1765db879a8dba6957017a9accda519135b4e0d068f0c926c6eb6ad6
Patch source
ctgov_internal_history
Generated at
2026-08-03T06:46:43.000Z
Source URL
Registry payload

Canonical JSON Preview

Stored payload
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  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT03735680_v9_v10_c37a64465442. ClinicalTrials.gov NCT03735680, versions 9-10. 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 9 to version 10 for NCT03735680.",
    "The JSON Patch for this comparison has hash 07493602bef2c37bc1fd6d8f599b2b18834c10d5111091aa0d43d13bbba7858b.",
    "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 path under serious adverse event results changed between ClinicalTrials.gov versions 9 and 10.",
    "The timing context for the from-version record was post_recruitment.",
    "The deterministic rules that fired were: adverse_event_group_change, serious_adverse_event_modification.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /resultsSection/participantFlowModule/groups/0/title, /resultsSection/participantFlowModule/groups/0/description, /resultsSection/participantFlowModule/groups/1, /resultsSection/participantFlowModule/groups/2, /resultsSection/participantFlowModule/groups/3, /resultsSection/participantFlowModule/groups/4, /resultsSection/participantFlowModule/groups/5, /resultsSection/participantFlowModule/periods/0/milestones/0/achievements/0/numSubjects, /resultsSection/participantFlowModule/periods/0/milestones/0/achievements/1, /resultsSection/participantFlowModule/periods/0/milestones/0/achievements/2, 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    {
      "op": "replace",
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    {
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    },
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  "review_question": "What source document explains the modified serious adverse event results record?",
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