{"changed_paths":["/protocolSection/statusModule/lastUpdateSubmitDate","/protocolSection/statusModule/lastUpdatePostDateStruct/date","/protocolSection/statusModule/resultsFirstSubmitQcDate","/protocolSection/statusModule/resultsFirstPostDateStruct","/protocolSection/outcomesModule/primaryOutcomes/1/description","/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame","/protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit","/protocolSection/outcomesModule/secondaryOutcomes","/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description","/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame","/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/reviewUnit","/resultsSection/outcomeMeasuresModule/outcomeMeasures/2","/resultsSection/adverseEventsModule/timeFrame","/resultsSection/adverseEventsModule/reviewUnit","/annotationSection","/reviewUnit"],"citation_text":"TrialDiff Evidence Record evt_NCT03094169_v12_v13_c3f7fc002262. ClinicalTrials.gov NCT03094169, versions 12-13. 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 12 to version 13 for NCT03094169.","The JSON Patch for this comparison has hash 9604949fcbf88d5fe8c63abc2aab36fc8d325cf7a750a78da87940c147716505.","The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.","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/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/outcomesModule/primaryOutcomes/1/description, /protocolSection/outcomesModule/primaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame, /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/reviewUnit, /resultsSection/outcomeMeasuresModule/outcomeMeasures/2, /resultsSection/adverseEventsModule/timeFrame, /resultsSection/adverseEventsModule/reviewUnit, /annotationSection, /reviewUnit.","An outcome path changed between versions 12 and 13 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":"74a6f55a686c29aa023171acd6b43f27ea95f2b0af2d49094ac70287ba4e502c","event_classes":["outcome_edit_cooccurs_with_results_posting"],"rule_set_hash":"fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621","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/1/description","/protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit","/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame"],"severity":"low","signal":"results_reconciliation_outcome_suppression"}]},"event_id":"evt_NCT03094169_v12_v13_c3f7fc002262","evidence_version":1,"patch":[{"op":"replace","path":"/protocolSection/statusModule/lastUpdateSubmitDate","value":"2025-05-23"},{"op":"replace","path":"/protocolSection/statusModule/lastUpdatePostDateStruct/date","value":"2025-06-11"},{"op":"add","path":"/protocolSection/statusModule/resultsFirstSubmitQcDate","value":"2025-05-23"},{"op":"add","path":"/protocolSection/statusModule/resultsFirstPostDateStruct","value":{"date":"2025-06-11","type":"ACTUAL"}},{"op":"replace","path":"/protocolSection/outcomesModule/primaryOutcomes/1/description","value":"<p>Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening and every 2 cycles during study treatment.</p><p>Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nPartial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.\nStable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.\nComplete Response (CR): Disappearance of all target lesions.\nAny pathological lymph nodes (whether target or non- target) must have reduction in short axis to &lt; 10 mm.</p>"},{"op":"replace","path":"/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame","value":"Imaging for Disease status (tumour measurements) occurred after every even cycle for the full duration of treatment and at EOT visit up to approximately 24 weeks total"},{"op":"remove","path":"/protocolSection/outcomesModule/primaryOutcomes/1/reviewUnit"},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes","value":[{"description":"Characterization of the pharmacokinetic profile of total antibody","measure":"PK Profile of Total Antibody","timeFrame":"Cycle 1 Profile (ie the first 3 weeks of dosing)"}]},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description","value":"<p>Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening and every 2 cycles during study treatment.</p><p>Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\nPartial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.\nStable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.\nComplete Response (CR): Disappearance of all target lesions.\nAny pathological lymph nodes (whether target or non- target) must have reduction in short axis to &lt; 10 mm.</p>"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame","value":"Imaging for Disease status (tumour measurements) occurred after every even cycle for the full duration of treatment and at EOT visit up to approximately 24 weeks total"},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/reviewUnit"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2","value":{"classes":[{"categories":[{"measurements":[{"comment":"BLQ (below detection limit)","groupId":"OG000","value":"NA"},{"comment":"BLQ (below detection limit)","groupId":"OG001","value":"NA"},{"comment":"BLQ (below detection limit)","groupId":"OG002","spread":"NA","value":"NA"},{"comment":"BLQ (below detection limit)","groupId":"OG003","spread":"NA","value":"NA"},{"comment":"BLQ (below detection limit)","groupId":"OG004","spread":"NA","value":"NA"},{"comment":"BLQ (below detection limit)","groupId":"OG005","spread":"NA","value":"NA"},{"comment":"BLQ (below detection limit)","groupId":"OG006","spread":"NA","value":"NA"},{"comment":"BLQ (below detection limit)","groupId":"OG007","spread":"NA","value":"NA"}]}],"title":"Cycle 1 D1 prior SOI"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9213.3"},{"groupId":"OG001","value":"13686.7"},{"groupId":"OG002","spread":"7472.0","value":"41140.7"},{"groupId":"OG003","spread":"9107.3","value":"71440.9"},{"groupId":"OG004","spread":"8517.2","value":"85982.9"},{"groupId":"OG005","spread":"18740.3","value":"113401.6"},{"groupId":"OG006","spread":"16938.5","value":"136306.3"},{"groupId":"OG007","spread":"20790.1","value":"122464.3"}]}],"title":"Cycle D1 EOI"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8066.3"},{"groupId":"OG001","value":"14003.5"},{"groupId":"OG002","spread":"7089.3","value":"36935.8"},{"groupId":"OG003","spread":"6199.4","value":"66587.4"},{"groupId":"OG004","spread":"6216.5","value":"89676.6"},{"groupId":"OG005","spread":"21616.7","value":"112663.3"},{"groupId":"OG006","spread":"10585.7","value":"131267.2"},{"comment":"Timepoint not assessed in Phase 2a expansion","groupId":"OG007","spread":"NA","value":"NA"}]}],"title":"Cycle 1 D1 2h post SOI"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8351.9"},{"groupId":"OG001","value":"14555.1"},{"groupId":"OG002","spread":"5940.6","value":"34399.7"},{"groupId":"OG003","spread":"4879.1","value":"61468.6"},{"groupId":"OG004","spread":"9542.3","value":"79581.1"},{"groupId":"OG005","spread":"17330.1","value":"101809.1"},{"groupId":"OG006","spread":"13243.3","value":"132671.4"},{"comment":"Timepoint not assessed in Phase 2a expansion","groupId":"OG007","spread":"NA","value":"NA"}]}],"title":"Cycle 1 D1 4h post SOI"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3217.6"},{"groupId":"OG001","value":"9390.7"},{"groupId":"OG002","spread":"2159.3","value":"25236.4"},{"groupId":"OG003","spread":"5940.3","value":"43504.6"},{"groupId":"OG004","spread":"5837.3","value":"63001.5"},{"groupId":"OG005","spread":"6605.4","value":"68284.5"},{"groupId":"OG006","spread":"13832.9","value":"99382.8"},{"comment":"Timepoint not assessed in Phase 2a expansion","groupId":"OG007","spread":"NA","value":"NA"}]}],"title":"Cycle 1 D2"},{"categories":[{"measurements":[{"groupId":"OG000","value":"876.3"},{"groupId":"OG001","value":"4578.3"},{"groupId":"OG002","spread":"1776.9","value":"14638.5"},{"groupId":"OG003","spread":"6859.7","value":"24985.3"},{"groupId":"OG004","spread":"5004.5","value":"35500.0"},{"groupId":"OG005","spread":"7890.3","value":"38068.0"},{"groupId":"OG006","spread":"10616.0","value":"69578.4"},{"comment":"Timepoint not assessed in Phase 2a expansion","groupId":"OG007","spread":"NA","value":"NA"}]}],"title":"Cycle 1 D4"},{"categories":[{"measurements":[{"comment":"BLQ (below detection limit)","groupId":"OG000","value":"NA"},{"comment":"BLQ (below detection limit)","groupId":"OG001","value":"NA"},{"groupId":"OG002","spread":"1422.7","value":"2450.7"},{"groupId":"OG003","spread":"5393.1","value":"8768.0"},{"groupId":"OG004","spread":"1531.9","value":"12590.0"},{"groupId":"OG005","spread":"3128.7","value":"18581.5"},{"groupId":"OG006","spread":"13531.7","value":"27982.5"},{"comment":"Timepoint not assessed in Phase 2a expansion","groupId":"OG007","spread":"NA","value":"NA"}]}],"title":"Cycle 1 D8"},{"categories":[{"measurements":[{"comment":"BLQ (below detection limit)","groupId":"OG000","value":"NA"},{"comment":"BLQ (below detection limit)","groupId":"OG001","value":"NA"},{"comment":"BLQ (below detection limit)","groupId":"OG002","spread":"NA","value":"NA"},{"comment":"BLQ (below detection limit)","groupId":"OG003","spread":"NA","value":"NA"},{"comment":"BLQ (below detection limit)","groupId":"OG004","spread":"NA","value":"NA"},{"comment":"BLQ (below detection limit)","groupId":"OG005","spread":"NA","value":"NA"},{"groupId":"OG006","spread":"855.8","value":"866.5"},{"groupId":"OG007","spread":"40.6","value":"131.1"}]}],"title":"Cycle 2 D1 prior to SOI"}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"6"},{"groupId":"OG006","value":"7"},{"groupId":"OG007","value":"9"}],"units":"Participants"}],"description":"Characterization of the pharmacokinetic profile of total antibody","dispersionType":"Standard Deviation","groups":[{"description":"Phase 1 Cohort 1: Participants were administered 20 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.","id":"OG000","title":"AVID100 20 mg&#x2F;m^2"},{"description":"Phase 1 Cohort 1: Participants were administered 40 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.","id":"OG001","title":"AVID100 40 mg&#x2F;m^2"},{"description":"Phase 1 Cohort 1: Participants were administered 80 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.","id":"OG002","title":"AVID100 80 mg&#x2F;m^2"},{"description":"Phase 1 Cohort 1: Participants were administered 120 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.","id":"OG003","title":"AVID100 120 mg&#x2F;m^2"},{"description":"Phase 1 Cohort 1: Participants were administered 180 mg&#x2F;m^2 of AVID100 every 3 weeks, via intravenous catheter (IV), for a minimum of 1 cycle, with 1 month of follow-up after the last dose was administered.","id":"OG004","title":"AVID100 180 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mg&#x2F;m^2"}],"paramType":"MEAN","populationDescription":"Patients who have completed Cycle 1 for which PK analysis was performed","reportingStatus":"POSTED","timeFrame":"Cycle 1 Profile (ie the first 3 weeks of dosing)","title":"PK Profile of Total Antibody","type":"SECONDARY","unitOfMeasure":"ng&#x2F;mL"}},{"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 up to approximately 28 weeks total."},{"op":"remove","path":"/resultsSection/adverseEventsModule/reviewUnit"},{"op":"remove","path":"/annotationSection"},{"op":"remove","path":"/reviewUnit"}],"provenance":{"from_snapshot_hash":"0683094728871f6e9dda89fc74f1b8dcb4447ecd0265f61555361eb7ea422663","materiality_event_hash":"42bb9a3487c434453df9d89aaa1369f4da9404f6584955373c41d7e95b1076da","patch_hash":"9604949fcbf88d5fe8c63abc2aab36fc8d325cf7a750a78da87940c147716505","patch_raw_hash":"e0ccf98d50c5349c6045b8348fd5e771a5d53a6f824955f5b3d668bbd18b3753","patch_source":"ctgov_internal_history","patch_source_url":"https://clinicaltrials.gov/api/int/studies/NCT03094169/history/12?patchToVersion=13","to_snapshot_hash":null},"review_question":"What source document explains this registry amendment, and does it change interpretation of the trial record?","schema":"trialdiff.evidence_record","trial":{"clinicaltrials_gov_url":"https://clinicaltrials.gov/study/NCT03094169","nct_id":"NCT03094169"},"versions":{"from_version":12,"submitted_date":"2025-05-23","to_version":13}}