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Evidence Record

evt_NCT03094169_v11_v12_7c55b4d1bf6c

NCT03094169 · AVID100 in Advanced Epithelial Carcinomas

View field-level diff Canonical JSON Supersession index ClinicalTrials.gov
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 Addition
Versions
v11 to v12
Timing
Post Recruitment

Claims Supported

  • TrialDiff compared ClinicalTrials.gov record version 11 to version 12 for NCT03094169.
  • The JSON Patch for this comparison has hash 3d5dde3b971aa66b49609f43fa3d6cb4b81265777150b9f399474daa9d67c6fd.
  • 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, secondary_outcome_removed_after_primary_completion.
  • A registry path under serious adverse event results was added between ClinicalTrials.gov versions 11 and 12.
  • The timing context for the from-version record was post_recruitment.
  • The deterministic rules that fired were: adverse_event_group_change, other_adverse_event_addition, other_adverse_event_modification, other_adverse_event_removal, serious_adverse_event_addition, serious_adverse_event_modification.
  • The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit, /protocolSection/outcomesModule/primaryOutcomes/1/measure, /protocolSection/outcomesModule/primaryOutcomes/1/description, /protocolSection/outcomesModule/primaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit/resetReasons/0, /protocolSection/outcomesModule/secondaryOutcomes, /resultsSection/participantFlowModule/groups/0/title, /resultsSection/participantFlowModule/groups/0/description, /resultsSection/participantFlowModule/groups/1/title, /resultsSection/participantFlowModule/groups/1/description, 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  • An outcome path changed between versions 11 and 12 in a patch that also carried a hasResults or resultsSection co-occurrence signal.
  • The JSON Patch removed a whole secondary outcome item after primary completion between versions 11 and 12; when a TO-version outcome list is available, reindex-only removals are excluded.

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 added serious adverse event results record?

Citation

TrialDiff Evidence Record evt_NCT03094169_v11_v12_7c55b4d1bf6c. ClinicalTrials.gov NCT03094169, versions 11-12. Evidence version 1.

Event Classes

outcome_edit_cooccurs_with_results_postingsecondary_outcome_removed_after_primary_completion

Changed Paths

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/resultsSection/adverseEventsModule/otherEvents/42/organSystem
/resultsSection/adverseEventsModule/otherEvents/42/sourceVocabulary
/resultsSection/adverseEventsModule/otherEvents/42/stats/0/numAtRisk
/resultsSection/adverseEventsModule/otherEvents/42/stats/1/numAtRisk
/resultsSection/adverseEventsModule/otherEvents/42/stats/2/numEvents
/resultsSection/adverseEventsModule/otherEvents/42/stats/2/numAffected
/resultsSection/adverseEventsModule/otherEvents/42/stats/2/numAtRisk
/resultsSection/adverseEventsModule/otherEvents/42/stats/4
/resultsSection/adverseEventsModule/otherEvents/42/stats/5
/resultsSection/adverseEventsModule/otherEvents/42/stats/6
/resultsSection/adverseEventsModule/otherEvents/42/stats/7
/resultsSection/adverseEventsModule/otherEvents/43/term
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/resultsSection/adverseEventsModule/otherEvents/43/stats/0/numAtRisk
/resultsSection/adverseEventsModule/otherEvents/43/stats/1/numAtRisk
/resultsSection/adverseEventsModule/otherEvents/43/stats/2/numEvents
/resultsSection/adverseEventsModule/otherEvents/43/stats/2/numAffected
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/resultsSection/adverseEventsModule/otherEvents/45/stats/0/numAtRisk
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/resultsSection/adverseEventsModule/otherEvents/48/term
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/resultsSection/adverseEventsModule/otherEvents/49/term
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/resultsSection/adverseEventsModule/otherEvents/49/stats/0/numAtRisk
/resultsSection/adverseEventsModule/otherEvents/49/stats/1/numAtRisk
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/resultsSection/adverseEventsModule/otherEvents/49/stats/4
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/resultsSection/adverseEventsModule/otherEvents/50
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/resultsSection/adverseEventsModule/otherEvents/50
/resultsSection/adverseEventsModule/otherEvents/50
/resultsSection/adverseEventsModule/otherEvents/50
/resultsSection/adverseEventsModule/otherEvents/50
/resultsSection/adverseEventsModule/otherEvents/50
/resultsSection/adverseEventsModule/otherEvents/50
/resultsSection/adverseEventsModule/otherEvents/50
/resultsSection/adverseEventsModule/otherEvents/50
/resultsSection/adverseEventsModule/otherEvents/50
/resultsSection/adverseEventsModule/otherEvents/50
/resultsSection/adverseEventsModule/armsReviewUnit
/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date
/reviewUnit

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

Deterministic Rules

adverse_event_group_changeother_adverse_event_additionother_adverse_event_modificationother_adverse_event_removalserious_adverse_event_additionserious_adverse_event_modification

Provenance

Package generation
v0.1.3 (active)
Supersedes
evt_NCT03094169_v11_v12_d44bd11b21cb
Patch hash
3d5dde3b971aa66b49609f43fa3d6cb4b81265777150b9f399474daa9d67c6fd
Canonical hash
19be8b0c22996790041e5adfcb53e34f3baf49d3d8abc15c061a5f2e90a5caf6
Rule set hash
fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621
From snapshot
c1651ac90d15af75bb072872aa2e524dc6163c44941e3c8c32eb1a5376c6e0aa
To snapshot
0683094728871f6e9dda89fc74f1b8dcb4447ecd0265f61555361eb7ea422663
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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    "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
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    "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
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    "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
    "/protocolSection/outcomesModule/primaryOutcomes/1/description",
    "/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame",
    "/protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit/resetReasons/0",
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    "/resultsSection/participantFlowModule/groups/7",
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    "/resultsSection/participantFlowModule/periods/0/milestones/0/achievements/1/numSubjects",
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    "/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/1/comment",
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    "/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/3/comment",
    "/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/4",
    "/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/5",
    "/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/6",
    "/resultsSection/participantFlowModule/periods/0/milestones/1/achievements/7",
    "/resultsSection/participantFlowModule/periods/0/milestones/2/achievements/4",
    "/resultsSection/participantFlowModule/periods/0/milestones/2/achievements/5",
    "/resultsSection/participantFlowModule/periods/0/milestones/2/achievements/6",
    "/resultsSection/participantFlowModule/periods/0/milestones/2/achievements/7",
    "/resultsSection/participantFlowModule/periods/0/dropWithdraws",
    "/resultsSection/participantFlowModule/reviewUnit",
    "/resultsSection/baselineCharacteristicsModule/groups/0/title",
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    "/resultsSection/baselineCharacteristicsModule/measures/0/classes/0/categories/0/measurements/8",
    "/resultsSection/baselineCharacteristicsModule/measures/0/classes/0/categories/1/measurements/0/value",
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    "/resultsSection/adverseEventsModule/otherEvents/49/stats/1/numAtRisk",
    "/resultsSection/adverseEventsModule/otherEvents/49/stats/2/numAffected",
    "/resultsSection/adverseEventsModule/otherEvents/49/stats/2/numAtRisk",
    "/resultsSection/adverseEventsModule/otherEvents/49/stats/4",
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    "/resultsSection/adverseEventsModule/otherEvents/50",
    "/resultsSection/adverseEventsModule/otherEvents/50",
    "/resultsSection/adverseEventsModule/otherEvents/50",
    "/resultsSection/adverseEventsModule/otherEvents/50",
    "/resultsSection/adverseEventsModule/otherEvents/50",
    "/resultsSection/adverseEventsModule/otherEvents/50",
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    "/resultsSection/adverseEventsModule/armsReviewUnit",
    "/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date",
    "/reviewUnit"
  ],
  "citation_text": "TrialDiff Evidence Record evt_NCT03094169_v11_v12_7c55b4d1bf6c. ClinicalTrials.gov NCT03094169, versions 11-12. 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 11 to version 12 for NCT03094169.",
    "The JSON Patch for this comparison has hash 3d5dde3b971aa66b49609f43fa3d6cb4b81265777150b9f399474daa9d67c6fd.",
    "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, secondary_outcome_removed_after_primary_completion.",
    "A registry path under serious adverse event results was added between ClinicalTrials.gov versions 11 and 12.",
    "The timing context for the from-version record was post_recruitment.",
    "The deterministic rules that fired were: adverse_event_group_change, other_adverse_event_addition, other_adverse_event_modification, other_adverse_event_removal, serious_adverse_event_addition, serious_adverse_event_modification.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit, /protocolSection/outcomesModule/primaryOutcomes/1/measure, /protocolSection/outcomesModule/primaryOutcomes/1/description, /protocolSection/outcomesModule/primaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit/resetReasons/0, /protocolSection/outcomesModule/secondaryOutcomes, /resultsSection/participantFlowModule/groups/0/title, /resultsSection/participantFlowModule/groups/0/description, /resultsSection/participantFlowModule/groups/1/title, /resultsSection/participantFlowModule/groups/1/description, 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    "An outcome path changed between versions 11 and 12 in a patch that also carried a hasResults or resultsSection co-occurrence signal.",
    "The JSON Patch removed a whole secondary outcome item after primary completion between versions 11 and 12; when a TO-version outcome list is available, reindex-only removals are excluded."
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  "classification": {
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    "rule_set_hash": "fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621",
    "severity": "high",
    "severity_pre_timing": "high",
    "timing_context": "post_recruitment",
    "triage_label": "high",
    "triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
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        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
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  "event_id": "evt_NCT03094169_v11_v12_7c55b4d1bf6c",
  "evidence_version": 1,
  "patch": [
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      "path": "/protocolSection/statusModule/statusVerifiedDate",
      "value": "2022-03"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
      "value": "2022-03-21"
    },
    {
      "op": "replace",
      "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
      "value": "2022-04-14"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
      "value": "Phase 1 Dose Escalation: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) in Cycle 1"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
      "value": "<p>Any of the following toxicities, if judged to be associated with study, were considered a DLT:</p><ol><li>Evidence of pulmonary fibrosis</li><li><p>G3 non-hematologic toxicity regardless of duration with the exceptions of:</p><ul><li>G3 nausea, vomiting, diarrhea, or fatigue lasting &lt; 2 days</li><li>G3 asymptomatic electrolyte abnormalities lasting &lt; 3 days not considered clinically relevant</li></ul></li><li>AST and&#x2F;or ALT elevation &gt; 3 x ULN with total bilirubin &gt; 2 x ULN without initial findings of cholestasis, that cannot be explained by other factors</li><li><p>Any G4 non-hematologic toxicity with the exception of:</p><p>• G4 asymptomatic electrolyte abnormalities lasting &lt; 7 days not considered clinically significant</p></li><li><p>Neutropenia that is:</p><ul><li>&gt; G3 and associated with fever</li><li>G4 and sustained (ANC &lt; 500 per mm3, duration &gt; 5 days)</li></ul></li><li><p>Thrombocytopenia that is:</p><ul><li>G3 with clinically significant hemorrhage or requirement for transfusion</li><li>G4 (platelets &lt; 25,000 per mm3)</li></ul></li><li>Inability to complete Cycle 1 at the assigned dose</li></ol>"
    },
    {
      "op": "replace",
      "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
      "value": "Cycle 1 during Dose Escalation (ie the first 3 weeks of dosing)"
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    },
    {
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    {
      "op": "replace",
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      "value": "Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening and every 2 cycles during study treatment."
    },
    {
      "op": "replace",
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      "value": "Imaging for Disease status (tumour measurements) occurred after every even cycle and at EOT visit"
    },
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      "op": "remove",
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    },
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    {
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    {
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    {
      "op": "replace",
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    {
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      "op": "add",
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        "id": "FG004",
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    },
    {
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        "description": "Participants from expanded populations of mTNBC, SCCHN, and Sq-NSCLC with documented EGFR expression received the maximum tolerated dose (MTD) determined in Phase 1, comprising AVID100 220 mg&#x2F;m^2 administered every 3 weeks IV, for at least 1 cycle.\nExtended treatment was permitted for participants tolerating and benefiting from treatment.",
        "id": "FG007",
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      }
    },
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    },
    {
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    {
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        "groupId": "OG004",
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        "groupId": "OG005",
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        "value": "2"
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    },
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      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/measureCategoriesReviewUnit"
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      "op": "replace",
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      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/populationDescription",
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      "op": "replace",
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    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/0/description",
      "value": "Participants from expanded populations of mTNBC, SCCHN, and Sq-NSCLC with documented EGFR expression received the maximum tolerated dose (MTD) determined in Phase 1, comprising AVID100 220 mg&#x2F;m^2 administered every 3 weeks IV, for at least 1 cycle.\nExtended treatment was permitted for participants tolerating and benefiting from treatment."
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/1"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/1"
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      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/1"
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    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/1"
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    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/1"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/1"
    },
    {
      "op": "replace",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/0/value",
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      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/1"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/1"
    },
    {
      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/measurements/1"
    },
    {
      "op": "add",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/0/title",
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    },
    {
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      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes/0/categories/1",
      "value": {
        "measurements": [
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        ],
        "title": "Stable Disease"
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        "measurements": [
          {
            "groupId": "OG000",
            "value": "1"
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        ],
        "title": "Complete Response"
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    },
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    {
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      "op": "remove",
      "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2"
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      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/timeFrame",
      "value": "Adverse event (AE) data was collected after informed consent was signed for treatment and up to 30days following their last treatment or until an adverse event was as resolved."
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    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/eventGroups/0/title",
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      "op": "replace",
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    {
      "op": "replace",
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    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/eventGroups/0/seriousNumAffected",
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    {
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    {
      "op": "replace",
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    {
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    {
      "op": "replace",
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    {
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    {
      "op": "replace",
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    {
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    {
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    },
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      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/eventGroups/2/seriousNumAffected",
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    {
      "op": "replace",
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      "value": 3
    },
    {
      "op": "replace",
      "path": "/resultsSection/adverseEventsModule/eventGroups/3/title",
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    {
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