Evidence Record
evt_NCT04278144_v33_v34_f64d3dc78625
NCT04278144 · A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors
Superseded Evidence Record
This page preserves the immutable v0.1.2 record. Its current successor is evt_NCT04278144_v33_v34_c2f5c01ccf14.
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
v33 to v34
Timing
Post Recruitment
Claims Supported
- TrialDiff compared ClinicalTrials.gov record version 33 to version 34 for NCT04278144.
- The JSON Patch for this comparison has hash f2d5a1dd5507f1d0bf07906057b4aacff8ad9e359f6925e9f2166dcc73eec71e.
- 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, secondary_outcome_removed_after_primary_completion.
- The timing context for the from-version record was post_recruitment.
- The changed JSON Pointer paths were: /protocolSection/statusModule/expandedAccessInfo, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/oversightModule/isUsExport, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/primaryOutcomes/1/measure, /protocolSection/outcomesModule/primaryOutcomes/1/description, /protocolSection/outcomesModule/primaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/2/measure, /protocolSection/outcomesModule/primaryOutcomes/2/description, /protocolSection/outcomesModule/primaryOutcomes/2/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/3, /protocolSection/outcomesModule/primaryOutcomes/3, /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/3/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/4/measure, /protocolSection/outcomesModule/secondaryOutcomes/4/description, /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/4/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/5/measure, /protocolSection/outcomesModule/secondaryOutcomes/5/description, /protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/5/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/6/measure, /protocolSection/outcomesModule/secondaryOutcomes/6/description, /protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/6/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/7, /protocolSection/outcomesModule/secondaryOutcomes/7, /protocolSection/outcomesModule/secondaryOutcomes/7, /protocolSection/outcomesModule/secondaryOutcomes/7, /protocolSection/outcomesModule/secondaryOutcomes/7, /protocolSection/outcomesModule/secondaryOutcomes/7, /protocolSection/outcomesModule/secondaryOutcomes/7, /protocolSection/contactsLocationsModule/locations/19/state, /protocolSection/contactsLocationsModule/locations/20/state, /hasResults, /resultsSection, /annotationSection, /documentSection.
- An outcome path changed between versions 33 and 34 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 33 and 34; 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 this registry amendment, and does it change interpretation of the trial record?
Citation
TrialDiff Evidence Record evt_NCT04278144_v33_v34_f64d3dc78625. ClinicalTrials.gov NCT04278144, versions 33-34. Evidence version 1.
Event Classes
outcome_edit_cooccurs_with_results_postingsecondary_outcome_removed_after_primary_completion Changed Paths
/protocolSection/statusModule/expandedAccessInfo
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/resultsFirstSubmitDate
/protocolSection/statusModule/resultsFirstSubmitQcDate
/protocolSection/statusModule/resultsFirstPostDateStruct
/protocolSection/oversightModule/isUsExport
/protocolSection/outcomesModule/primaryOutcomes/0/measure
/protocolSection/outcomesModule/primaryOutcomes/0/description
/protocolSection/outcomesModule/primaryOutcomes/1/measure
/protocolSection/outcomesModule/primaryOutcomes/1/description
/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame
/protocolSection/outcomesModule/primaryOutcomes/2/measure
/protocolSection/outcomesModule/primaryOutcomes/2/description
/protocolSection/outcomesModule/primaryOutcomes/2/timeFrame
/protocolSection/outcomesModule/primaryOutcomes/3
/protocolSection/outcomesModule/primaryOutcomes/3
/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/3/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit
/protocolSection/outcomesModule/secondaryOutcomes/4/measure
/protocolSection/outcomesModule/secondaryOutcomes/4/description
/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/4/reviewUnit
/protocolSection/outcomesModule/secondaryOutcomes/5/measure
/protocolSection/outcomesModule/secondaryOutcomes/5/description
/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/5/reviewUnit
/protocolSection/outcomesModule/secondaryOutcomes/6/measure
/protocolSection/outcomesModule/secondaryOutcomes/6/description
/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/6/reviewUnit
/protocolSection/outcomesModule/secondaryOutcomes/7
/protocolSection/outcomesModule/secondaryOutcomes/7
/protocolSection/outcomesModule/secondaryOutcomes/7
/protocolSection/outcomesModule/secondaryOutcomes/7
/protocolSection/outcomesModule/secondaryOutcomes/7
/protocolSection/outcomesModule/secondaryOutcomes/7
/protocolSection/outcomesModule/secondaryOutcomes/7
/protocolSection/contactsLocationsModule/locations/19/state
/protocolSection/contactsLocationsModule/locations/20/state
/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_NCT04278144_v33_v34_c2f5c01ccf14
- Patch hash
f2d5a1dd5507f1d0bf07906057b4aacff8ad9e359f6925e9f2166dcc73eec71e- Canonical hash
d96faa8297dc182164e63da59def65b831533a0780ecdbeb133325d273d616f0- Rule set hash
318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86- From snapshot
3368a1c3c06854f4d99abc9c4679ad7cb984abad74203405773b8e5cc9cd4688- To snapshot
Unavailable- 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/expandedAccessInfo",
"/protocolSection/statusModule/lastUpdateSubmitDate",
"/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"/protocolSection/statusModule/resultsFirstSubmitDate",
"/protocolSection/statusModule/resultsFirstSubmitQcDate",
"/protocolSection/statusModule/resultsFirstPostDateStruct",
"/protocolSection/oversightModule/isUsExport",
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"/protocolSection/outcomesModule/primaryOutcomes/0/description",
"/protocolSection/outcomesModule/primaryOutcomes/1/measure",
"/protocolSection/outcomesModule/primaryOutcomes/1/description",
"/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame",
"/protocolSection/outcomesModule/primaryOutcomes/2/measure",
"/protocolSection/outcomesModule/primaryOutcomes/2/description",
"/protocolSection/outcomesModule/primaryOutcomes/2/timeFrame",
"/protocolSection/outcomesModule/primaryOutcomes/3",
"/protocolSection/outcomesModule/primaryOutcomes/3",
"/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/3/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/4/description",
"/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/4/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/5/description",
"/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/5/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/6/description",
"/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/6/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/7",
"/protocolSection/outcomesModule/secondaryOutcomes/7",
"/protocolSection/outcomesModule/secondaryOutcomes/7",
"/protocolSection/outcomesModule/secondaryOutcomes/7",
"/protocolSection/outcomesModule/secondaryOutcomes/7",
"/protocolSection/outcomesModule/secondaryOutcomes/7",
"/protocolSection/outcomesModule/secondaryOutcomes/7",
"/protocolSection/contactsLocationsModule/locations/19/state",
"/protocolSection/contactsLocationsModule/locations/20/state",
"/hasResults",
"/resultsSection",
"/annotationSection",
"/documentSection"
],
"citation_text": "TrialDiff Evidence Record evt_NCT04278144_v33_v34_f64d3dc78625. ClinicalTrials.gov NCT04278144, versions 33-34. 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 33 to version 34 for NCT04278144.",
"The JSON Patch for this comparison has hash f2d5a1dd5507f1d0bf07906057b4aacff8ad9e359f6925e9f2166dcc73eec71e.",
"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, secondary_outcome_removed_after_primary_completion.",
"The timing context for the from-version record was post_recruitment.",
"The changed JSON Pointer paths were: /protocolSection/statusModule/expandedAccessInfo, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/oversightModule/isUsExport, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/primaryOutcomes/1/measure, /protocolSection/outcomesModule/primaryOutcomes/1/description, /protocolSection/outcomesModule/primaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/2/measure, /protocolSection/outcomesModule/primaryOutcomes/2/description, /protocolSection/outcomesModule/primaryOutcomes/2/timeFrame, /protocolSection/outcomesModule/primaryOutcomes/3, /protocolSection/outcomesModule/primaryOutcomes/3, /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/3/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/4/measure, /protocolSection/outcomesModule/secondaryOutcomes/4/description, /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/4/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/5/measure, /protocolSection/outcomesModule/secondaryOutcomes/5/description, /protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/5/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/6/measure, /protocolSection/outcomesModule/secondaryOutcomes/6/description, /protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/6/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/7, /protocolSection/outcomesModule/secondaryOutcomes/7, /protocolSection/outcomesModule/secondaryOutcomes/7, /protocolSection/outcomesModule/secondaryOutcomes/7, /protocolSection/outcomesModule/secondaryOutcomes/7, /protocolSection/outcomesModule/secondaryOutcomes/7, /protocolSection/outcomesModule/secondaryOutcomes/7, /protocolSection/contactsLocationsModule/locations/19/state, /protocolSection/contactsLocationsModule/locations/20/state, /hasResults, /resultsSection, /annotationSection, /documentSection.",
"An outcome path changed between versions 33 and 34 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 33 and 34; when a TO-version outcome list is available, reindex-only removals are excluded."
],
"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",
"secondary_outcome_removed_after_primary_completion"
],
"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/measure",
"/protocolSection/outcomesModule/primaryOutcomes/1/description",
"/protocolSection/outcomesModule/primaryOutcomes/1/measure",
"/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame",
"/protocolSection/outcomesModule/primaryOutcomes/2/description",
"/protocolSection/outcomesModule/primaryOutcomes/2/measure",
"/protocolSection/outcomesModule/primaryOutcomes/2/timeFrame",
"/protocolSection/outcomesModule/primaryOutcomes/3",
"/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/3/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/4/description",
"/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/4/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/5/description",
"/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/5/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/6/description",
"/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/6/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/7"
],
"severity": "low",
"signal": "results_reconciliation_outcome_suppression"
}
]
},
"event_id": "evt_NCT04278144_v33_v34_f64d3dc78625",
"evidence_version": 1,
"patch": [
{
"op": "remove",
"path": "/protocolSection/statusModule/expandedAccessInfo"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2025-12-10"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2025-12-30"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2025-12-10"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2025-12-10"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2025-12-30",
"type": "ACTUAL"
}
},
{
"op": "remove",
"path": "/protocolSection/oversightModule/isUsExport"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Incidence of Treatment Emergent Adverse Events (TEAEs)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "Number of participants with at least 1 TEAE graded according to NCI CTCAE v5.0"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
"value": "Incidence of Participants With Serious TEAEs"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1/description",
"value": "Number of participants with at least 1 Serious TEAE graded according to NCI CTCAE v5.0."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame",
"value": "2 years"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/2/measure",
"value": "Incidence Dose-limiting Toxicities (DLTs)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/2/description",
"value": "DLTs occurring in the first 21 days after study drug administration"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/2/timeFrame",
"value": "Up to 21 days"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/primaryOutcomes/3"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/primaryOutcomes/3"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Objective Response Rate (ORR)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"value": "Objective Response Rate (ORR) was defined as the proportion of participants with best overall response of confirmed Complete Response (CR) or Partial Response (PR) as determined by the treating Investigator using RECIST v1.1 criteria."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"value": "Duration of Response (DOR)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
"value": "Duration of Response (DOR) was calculated for participants who achieved confirmed CR or PR.\nFor such participants, DOR is defined as the duration from the start date of CR or PR (whichever response status is observed first) and subsequently confirmed, to the earliest of documented date of PD per RECIST v 1.1 or death."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"value": "Progression Free Survival (PFS)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"value": "Progression-free survival (PFS) was defined as the duration from the date of first study treatment administration (Cycle 1 Day 1) to the earliest date of documented PD per RECIST v1.1 or death.\nA death was considered a PFS event."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"value": "Treatment Induced Incidence of Anti-BDC-1001 Antibodies (ADA)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
"value": "Formation of ADA has been monitored with a bridging enzyme linked immune-absorbent assay (ELISA) assay.\nThe confirmatory assay had a sensitivity of 127 ng/mL, drug tolerance of up to 60-fold more drug than ADAs, soluble HER2 tolerance of 250 ng/mL and tolerance of interference from nivolumab of 100 ug/mL.\nDetection of treatment-induced ADAs was not associated with alteration of BDC-1001 exposure, increased AEs, nor disease progression."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
"value": "Pre-infusion at Cycle 1 and 3, and then pre-infusion every 2 - 4 weeks, until treatment termination."
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit",
"value": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
"value": "Minimum Serum Concentration (Cmin) of BDC-1001"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
"value": "Cmin at steady state for BDC-1001 was calculated from serum concentrations using Population PK analysis."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
"value": "Pre-infusion and at end of infusion for Cycles 1-4, at 1 hour and 4 hours post-infusion during Cycles 1-3 with additional samples at specified visits, and then pre-infusion and at end of infusion every 4 - 6 weeks, until treatment termination."
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/reviewUnit",
"value": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
"value": "Maximum Serum Concentration (Cmax) of BDC-1001"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
"value": "Cmax at steady state for BDC-1001 was calculated from serum concentrations using Population PK analysis."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
"value": "Pre-infusion and at end of infusion for Cycles 1-4, at 1 hour and 4 hours post-infusion during Cycles 1-3 with additional samples at specified visits, and then pre-infusion and at end of infusion every 4 - 6 weeks, until treatment termination."
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/reviewUnit",
"value": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
"value": "Area Under the Curve (AUC) of BDC-1001"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/description",
"value": "Area under the concentration-time curve (AUC), calculated over the dosing interval following repeated dosing"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame",
"value": "Pre-infusion and at end of infusion for Cycles 1-4, at 1 hour and 4 hours post-infusion during Cycles 1-3 with additional samples at specified visits, and then pre-infusion and at end of infusion every 4 - 6 weeks, until treatment termination."
},
{
"op": "add",
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{
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p><p>Nivolumab: Programmed death receptor-1 (PD 1)-blocking antibody</p>",
"id": "OG001",
"title": "Combination BDC-1001 Plus Nivolumab - Dose Escalation"
}
],
"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": "2 years",
"title": "Incidence of Participants With Serious TEAEs",
"type": "PRIMARY",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0"
},
{
"groupId": "OG001",
"value": "1"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "93"
},
{
"groupId": "OG001",
"value": "34"
}
],
"units": "Participants"
}
],
"description": "DLTs occurring in the first 21 days after study drug administration",
"groups": [
{
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p>",
"id": "OG000",
"title": "Single Agent BDC-1001"
},
{
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p><p>Nivolumab: Programmed death receptor-1 (PD 1)-blocking antibody</p>",
"id": "OG001",
"title": "Combination BDC-1001 Plus Nivolumab"
}
],
"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",
"populationDescription": "DLT by Preferred Term in DLT Evaluable Population",
"reportingStatus": "POSTED",
"timeFrame": "Up to 21 days",
"title": "Incidence Dose-limiting Toxicities (DLTs)",
"type": "PRIMARY",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "4"
},
{
"groupId": "OG001",
"value": "3"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "122"
},
{
"groupId": "OG001",
"value": "32"
}
],
"units": "Participants"
}
],
"description": "Objective Response Rate (ORR) was defined as the proportion of participants with best overall response of confirmed Complete Response (CR) or Partial Response (PR) as determined by the treating Investigator using RECIST v1.1 criteria.",
"groups": [
{
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p>",
"id": "OG000",
"title": "Single Agent BDC-1001"
},
{
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p><p>Nivolumab: Programmed death receptor-1 (PD 1)-blocking antibody</p>",
"id": "OG001",
"title": "Combination BDC-1001 Plus Nivolumab"
}
],
"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",
"populationDescription": "Rates were based on participants who were tumor evaluable (had at least one baseline and one post-baseline tumor response data).",
"reportingStatus": "POSTED",
"timeFrame": "2 years",
"title": "Objective Response Rate (ORR)",
"type": "SECONDARY",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"comment": "It was not possible to calculate the upper 95% confidence interval due to the insufficient number of participants with events.",
"groupId": "OG000",
"lowerLimit": "5.82",
"upperLimit": "NA",
"value": "13.17"
},
{
"comment": "It was not possible to calculate the upper 95% confidence interval due to the insufficient number of participants with events.",
"groupId": "OG001",
"lowerLimit": "2.76",
"upperLimit": "NA",
"value": "5.68"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "138"
},
{
"groupId": "OG001",
"value": "37"
}
],
"units": "Participants"
}
],
"description": "Duration of Response (DOR) was calculated for participants who achieved confirmed CR or PR.\nFor such participants, DOR is defined as the duration from the start date of CR or PR (whichever response status is observed first) and subsequently confirmed, to the earliest of documented date of PD per RECIST v 1.1 or death.",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p>",
"id": "OG000",
"title": "Single Agent BDC-1001"
},
{
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p><p>Nivolumab: Programmed death receptor-1 (PD 1)-blocking antibody</p>",
"id": "OG001",
"title": "Combination BDC-1001 Plus Nivolumab"
}
],
"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.",
"The number of participants analyzed appears inconsistent with data here or in other parts of the record."
]
},
"paramType": "MEDIAN",
"populationDescription": "DOR was calculated based on the total number of participants who had CR or PR in each cohort.",
"reportingStatus": "POSTED",
"timeFrame": "2 years",
"title": "Duration of Response (DOR)",
"type": "SECONDARY",
"unitOfMeasure": "Months"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "1.25",
"upperLimit": "1.41",
"value": "1.38"
},
{
"groupId": "OG001",
"lowerLimit": "1.22",
"upperLimit": "4.11",
"value": "1.40"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "138"
},
{
"groupId": "OG001",
"value": "37"
}
],
"units": "Participants"
}
],
"description": "Progression-free survival (PFS) was defined as the duration from the date of first study treatment administration (Cycle 1 Day 1) to the earliest date of documented PD per RECIST v1.1 or death.\nA death was considered a PFS event.",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p>",
"id": "OG000",
"title": "Single Agent BDC-1001"
},
{
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p><p>Nivolumab: Programmed death receptor-1 (PD 1)-blocking antibody</p>",
"id": "OG001",
"title": "Combination BDC-1001 Plus Nivolumab"
}
],
"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": "MEDIAN",
"populationDescription": "Rates were based on participants who have at least one baseline and one post-baseline Tumor Response data.",
"reportingStatus": "POSTED",
"timeFrame": "2 years",
"title": "Progression Free Survival (PFS)",
"type": "SECONDARY",
"unitOfMeasure": "Months"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "11"
},
{
"groupId": "OG001",
"value": "7"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "129"
},
{
"groupId": "OG001",
"value": "37"
}
],
"units": "Participants"
}
],
"description": "Formation of ADA has been monitored with a bridging enzyme linked immune-absorbent assay (ELISA) assay.\nThe confirmatory assay had a sensitivity of 127 ng/mL, drug tolerance of up to 60-fold more drug than ADAs, soluble HER2 tolerance of 250 ng/mL and tolerance of interference from nivolumab of 100 ug/mL.\nDetection of treatment-induced ADAs was not associated with alteration of BDC-1001 exposure, increased AEs, nor disease progression.",
"groups": [
{
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p>",
"id": "OG000",
"title": "Single Agent BDC-1001"
},
{
"description": "<p>Escalating doses followed by expansion targeting HER2-expressing advanced malignancies</p><p>BDC-1001: Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist</p><p>Nivolumab: Programmed death receptor-1 (PD 1)-blocking antibody</p>",
"id": "OG001",
"title": "Combination BDC-1001 Plus Nivolumab"
}
],
"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",
"populationDescription": "Evaluable participants with any baseline or post baseline ADA assessment.",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "Pre-infusion at Cycle 1 and 3, and then pre-infusion every 2 - 4 weeks, until treatment termination.",
"title": "Treatment Induced Incidence of Anti-BDC-1001 Antibodies (ADA)",
"type": "SECONDARY",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "0.0016",
"upperLimit": "3.1",
"value": "0.13"
},
{
"groupId": "OG001",
"lowerLimit": "0.01",
"upperLimit": "2.4",
"value": "0.78"
},
{
"groupId": "OG002",
"lowerLimit": "0.069",
"upperLimit": "4.5",
"value": "1.0"
},
{
"groupId": "OG003",
"lowerLimit": "0.82",
"upperLimit": "5.6",
"value": "2.9"
},
{
"groupId": "OG004",
"lowerLimit": "1.04",
"upperLimit": "20",
"value": "2.7"
},
{
"groupId": "OG005",
"lowerLimit": "1.6",
"upperLimit": "11",
"value": "5.5"
},
{
"groupId": "OG006",
"lowerLimit": "0.35",
"upperLimit": "19",
"value": "14"
},
{
"groupId": "OG007",
"lowerLimit": "13",
"upperLimit": "41",
"value": "16"
},
{
"groupId": "OG008",
"lowerLimit": "13",
"upperLimit": "120",
"value": "44"
},
{
"groupId": "OG009",
"lowerLimit": "20",
"upperLimit": "66",
"value": "36"
},
{
"groupId": "OG010",
"lowerLimit": "1.5",
"upperLimit": "17",
"value": "3.1"
},
{
"groupId": "OG011",
"lowerLimit": "0.091",
"upperLimit": "79",
"value": "10"
},
{
"groupId": "OG012",
"lowerLimit": "9.8",
"upperLimit": "48",
"value": "18"
},
{
"groupId": "OG013",
"lowerLimit": "11",
"upperLimit": "40",
"value": "12"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "15"
},
{
"groupId": "OG001",
"value": "11"
},
{
"groupId": "OG002",
"value": "8"
},
{
"groupId": "OG003",
"value": "10"
},
{
"groupId": "OG004",
"value": "5"
},
{
"groupId": "OG005",
"value": "8"
},
{
"groupId": "OG006",
"value": "7"
},
{
"groupId": "OG007",
"value": "4"
},
{
"groupId": "OG008",
"value": "9"
},
{
"groupId": "OG009",
"value": "4"
},
{
"groupId": "OG010",
"value": "7"
},
{
"groupId": "OG011",
"value": "7"
},
{
"groupId": "OG012",
"value": "9"
},
{
"groupId": "OG013",
"value": "3"
}
],
"units": "Participants"
}
],
"description": "Cmin at steady state for BDC-1001 was calculated from serum concentrations using Population PK analysis.",
"dispersionType": "Full Range",
"groups": [
{
"description": "Participants received 5 mg/kg of BDC-1001 intravenously (IV) once every 3 weeks (q3w) on Day 1 of 21-day cycles",
"id": "OG000",
"title": "BDC-1001 5 mg/kg q3w"
},
{
"description": "Participants received 8 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 3 weeks (q3w)",
"id": "OG001",
"title": "BDC-1001 8 mg/kg q3w"
},
{
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 3 weeks (q3w)",
"id": "OG002",
"title": "BDC-1001 12 mg/kg q3w"
},
{
"description": "Participants received 20 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 3 weeks (q3w)",
"id": "OG003",
"title": "BDC-1001 20 mg/kg q3w"
},
{
"description": "Participants received 8 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 2 weeks (q2w)",
"id": "OG004",
"title": "BDC-1001 8 mg/kg q2w"
},
{
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 2 weeks (q2w)",
"id": "OG005",
"title": "BDC-1001 12 mg/kg q2w"
},
{
"description": "Participants received 20 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 2 weeks (q2w)",
"id": "OG006",
"title": "BDC-1001 20 mg/kg q2w"
},
{
"description": "Participants received 8 mg/kg of BDC-1001 intravenously (IV) on Day 1 every week (q1w)",
"id": "OG007",
"title": "BDC-1001 8 mg/kg q1w"
},
{
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) on Day 1 every week (q1w)",
"id": "OG008",
"title": "BDC-1001 12 mg/kg q1w"
},
{
"description": "Participants received 20 mg/kg of BDC-1001 intravenously (IV) on Day 1 every week (q1w)",
"id": "OG009",
"title": "BDC-1001 20 mg/kg q1w"
},
{
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) and 360 mg nivolumab on Day 1 every 2 weeks (q2w)",
"id": "OG010",
"title": "BDC-1001 12 mg/kg + Nivolumab q2w"
},
{
"description": "Participants received 20 mg/kg of BDC-1001 intravenously (IV) and 360 mg nivolumab on Day 1 every 2 weeks (q2w)",
"id": "OG011",
"title": "BDC-1001 20 mg/kg + Nivolumab q2w"
},
{
"description": "Participants received 8 mg/kg of BDC-1001 intravenously (IV) and 240 mg nivolumab on Day 1 every 1 week (q1w)",
"id": "OG012",
"title": "BDC-1001 8 mg/kg + Nivolumab q1w"
},
{
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) and 240 mg nivolumab on Day 1 every 1 week (q1w)",
"id": "OG013",
"title": "BDC-1001 12 mg/kg + Nivolumab q1w"
}
],
"paramType": "MEDIAN",
"populationDescription": "Participants who received at least one dose of BDC-1001 and had at least one evaluable post-dose PK concentration.",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "Pre-infusion and at end of infusion for Cycles 1-4, at 1 hour and 4 hours post-infusion during Cycles 1-3 with additional samples at specified visits, and then pre-infusion and at end of infusion every 4 - 6 weeks, until treatment termination.",
"title": "Minimum Serum Concentration (Cmin) of BDC-1001",
"type": "SECONDARY",
"unitOfMeasure": "µg/mL"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "75",
"upperLimit": "120",
"value": "96"
},
{
"groupId": "OG001",
"lowerLimit": "80",
"upperLimit": "150",
"value": "110"
},
{
"groupId": "OG002",
"lowerLimit": "93",
"upperLimit": "200",
"value": "150"
},
{
"groupId": "OG003",
"lowerLimit": "220",
"upperLimit": "380",
"value": "290"
},
{
"groupId": "OG004",
"lowerLimit": "88",
"upperLimit": "180",
"value": "150"
},
{
"groupId": "OG005",
"lowerLimit": "160",
"upperLimit": "250",
"value": "200"
},
{
"groupId": "OG006",
"lowerLimit": "270",
"upperLimit": "350",
"value": "300"
},
{
"groupId": "OG007",
"lowerLimit": "110",
"upperLimit": "180",
"value": "140"
},
{
"groupId": "OG008",
"lowerLimit": "120",
"upperLimit": "400",
"value": "220"
},
{
"groupId": "OG009",
"lowerLimit": "280",
"upperLimit": "510",
"value": "360"
},
{
"groupId": "OG010",
"lowerLimit": "160",
"upperLimit": "280",
"value": "210"
},
{
"groupId": "OG011",
"lowerLimit": "270",
"upperLimit": "480",
"value": "340"
},
{
"groupId": "OG012",
"lowerLimit": "140",
"upperLimit": "200",
"value": "160"
},
{
"groupId": "OG013",
"lowerLimit": "160",
"upperLimit": "270",
"value": "170"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "15"
},
{
"groupId": "OG001",
"value": "11"
},
{
"groupId": "OG002",
"value": "8"
},
{
"groupId": "OG003",
"value": "10"
},
{
"groupId": "OG004",
"value": "5"
},
{
"groupId": "OG005",
"value": "8"
},
{
"groupId": "OG006",
"value": "7"
},
{
"groupId": "OG007",
"value": "4"
},
{
"groupId": "OG008",
"value": "9"
},
{
"groupId": "OG009",
"value": "4"
},
{
"groupId": "OG010",
"value": "7"
},
{
"groupId": "OG011",
"value": "7"
},
{
"groupId": "OG012",
"value": "9"
},
{
"groupId": "OG013",
"value": "3"
}
],
"units": "Participants"
}
],
"description": "Cmax at steady state for BDC-1001 was calculated from serum concentrations using Population PK analysis.",
"dispersionType": "Full Range",
"groups": [
{
"description": "Participants received 5 mg/kg of BDC-1001 intravenously (IV) once every 3 weeks (q3w) on Day 1 of 21-day cycles",
"id": "OG000",
"title": "BDC-1001 5 mg/kg q3w"
},
{
"description": "Participants received 8 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 3 weeks (q3w)",
"id": "OG001",
"title": "BDC-1001 8 mg/kg q3w"
},
{
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 3 weeks (q3w)",
"id": "OG002",
"title": "BDC-1001 12 mg/kg q3w"
},
{
"description": "Participants received 20 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 3 weeks (q3w)",
"id": "OG003",
"title": "BDC-1001 20 mg/kg q3w"
},
{
"description": "Participants received 8 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 2 weeks (q2w)",
"id": "OG004",
"title": "BDC-1001 8 mg/kg q2w"
},
{
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 2 weeks (q2w)",
"id": "OG005",
"title": "BDC-1001 12 mg/kg q2w"
},
{
"description": "Participants received 20 mg/kg of BDC-1001 intravenously (IV) on Day 1 every 2 weeks (q2w)",
"id": "OG006",
"title": "BDC-1001 20 mg/kg q2w"
},
{
"description": "Participants received 8 mg/kg of BDC-1001 intravenously (IV) on Day 1 every week (q1w)",
"id": "OG007",
"title": "BDC-1001 8 mg/kg q1w"
},
{
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) on Day 1 every week (q1w)",
"id": "OG008",
"title": "BDC-1001 12 mg/kg q1w"
},
{
"description": "Participants received 20 mg/kg of BDC-1001 intravenously (IV) on Day 1 every week (q1w)",
"id": "OG009",
"title": "BDC-1001 20 mg/kg q1w"
},
{
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) and 360 mg nivolumab on Day 1 every 2 weeks (q2w)",
"id": "OG010",
"title": "BDC-1001 12 mg/kg + Nivolumab q2w"
},
{
"description": "Participants received 20 mg/kg of BDC-1001 intravenously (IV) and 360 mg nivolumab on Day 1 every 2 weeks (q2w)",
"id": "OG011",
"title": "BDC-1001 20 mg/kg + Nivolumab q2w"
},
{
"description": "Participants received 8 mg/kg of BDC-1001 intravenously (IV) and 240 mg nivolumab on Day 1 every 1 week (q1w)",
"id": "OG012",
"title": "BDC-1001 8 mg/kg + Nivolumab q1w"
},
{
"description": "Participants received 12 mg/kg of BDC-1001 intravenously (IV) and 240 mg nivolumab on Day 1 every 1 week (q1w)",
"id": "OG013",
"title": "BDC-1001 12 mg/kg + Nivolumab q1w"
}
],
"paramType": "MEDIAN",
"populationDescription": "Participants who received at least one dose of BDC-1001 and had at least one evaluable post-dose PK concentration.",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "Pre-infusion and at end of infusion for Cycles 1-4, at 1 hour and 4 hours post-infusion during Cycles 1-3 with additional samples at specified visits, and then pre-infusion and at end of infusion every 4 - 6 weeks, until treatment termination.",
"title": "Maximum Serum Concentration (Cmax) of BDC-1001",
"type": "SECONDARY",
"unitOfMeasure": "µg/mL"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "210",
"upperLimit": "760",
"value": "380"
},
{
"groupId": "OG001",
"lowerLimit": "360",
"upperLimit": "900",
"value": "640"
},
{
"groupId": "OG002",
"lowerLimit": "600",
"upperLimit": "1400",
"value": "760"
},
{
"groupId": "OG003",
"lowerLimit": "1200",
"upperLimit": "2300",
"value": "1500"
},
{
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