Evidence Record
evt_NCT02229084_v16_v17_82fce4512999
NCT02229084 · Vaccination of High Risk Breast Cancer Patients
Superseded Evidence Record
This page preserves the immutable v0.1.2 record. Its current successor is evt_NCT02229084_v16_v17_bc317e7b2822.
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
Arm Intervention Change
Versions
v16 to v17
Timing
Post Recruitment
Claims Supported
- TrialDiff compared ClinicalTrials.gov record version 16 to version 17 for NCT02229084.
- The JSON Patch for this comparison has hash 789cb904ff1f6324a6e8dc03fb7fa44b6ff9c645a79f0ab817bb68c4caf1daa1.
- The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.
- 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 field under an arm or intervention module changed between ClinicalTrials.gov versions 16 and 17.
- The timing context for the from-version record was post_recruitment.
- The deterministic rules that fired were: arms_or_interventions_change, enrollment_count_change.
- The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/descriptionModule/detailedDescription, /protocolSection/designModule/enrollmentInfo/count, /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0, /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1, /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2, /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/3, /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0, /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/1, /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/2, /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/3, /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0, /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/1, /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/2, /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/3, /protocolSection/armsInterventionsModule/armGroups/3/interventionNames/0, /protocolSection/armsInterventionsModule/armGroups/3/interventionNames/1, /protocolSection/armsInterventionsModule/armGroups/3/interventionNames/2, /protocolSection/armsInterventionsModule/armGroups/3/interventionNames/3, /protocolSection/armsInterventionsModule/armGroups/4/interventionNames/0, /protocolSection/armsInterventionsModule/armGroups/4/interventionNames/1, /protocolSection/armsInterventionsModule/armGroups/4/interventionNames/2, /protocolSection/armsInterventionsModule/armGroups/4/interventionNames/3, /protocolSection/armsInterventionsModule/armGroups/5/interventionNames/0, /protocolSection/armsInterventionsModule/armGroups/5/interventionNames/1, /protocolSection/armsInterventionsModule/armGroups/5/interventionNames/2, /protocolSection/armsInterventionsModule/armGroups/5/interventionNames/3, /protocolSection/armsInterventionsModule/armGroups/6/interventionNames/0, /protocolSection/armsInterventionsModule/armGroups/6/interventionNames/1, /protocolSection/armsInterventionsModule/armGroups/6/interventionNames/2, /protocolSection/armsInterventionsModule/armGroups/6/interventionNames/3, /protocolSection/armsInterventionsModule/interventions/0/name, /protocolSection/armsInterventionsModule/interventions/0/description, /protocolSection/armsInterventionsModule/interventions/0/otherNames, /protocolSection/armsInterventionsModule/interventions/1, /protocolSection/armsInterventionsModule/interventions/2, /protocolSection/armsInterventionsModule/interventions/3, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/1/measure, /protocolSection/outcomesModule/primaryOutcomes/1/description, /protocolSection/outcomesModule/primaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes, /annotationSection, /documentSection/largeDocumentModule/largeDocs/1/uploadDate, /documentSection/largeDocumentModule/largeDocs/1/filename, /documentSection/largeDocumentModule/largeDocs/1/size, /hasResults, /resultsSection.
- An outcome path changed between versions 16 and 17 in a patch that also carried a hasResults or resultsSection co-occurrence signal.
Claims Not Supported
- That the amendment was scientifically unjustified.
- That the change constitutes misconduct or wrongdoing.
- That sponsor intent can be inferred from this registry change.
- That the change caused or altered the trial's results.
- That the change was or was not disclosed in a manuscript.
- That TrialDiff determines regulatory compliance or non-compliance.
- That co-occurrence with results posting proves the outcome edit was harmless, administrative, or substantively benign.
- That event-class membership is a validated global review-priority ranking.
Neutral Review Question
What source document explains this registry amendment, and does it change interpretation of the trial record?
Citation
TrialDiff Evidence Record evt_NCT02229084_v16_v17_82fce4512999. ClinicalTrials.gov NCT02229084, versions 16-17. Evidence version 1.
Event Classes
outcome_edit_cooccurs_with_results_posting Changed Paths
/protocolSection/statusModule/statusVerifiedDate
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/resultsFirstSubmitDate
/protocolSection/statusModule/resultsFirstSubmitQcDate
/protocolSection/statusModule/resultsFirstPostDateStruct
/protocolSection/descriptionModule/detailedDescription
/protocolSection/designModule/enrollmentInfo/count
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/3
/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/1
/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/2
/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/3
/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/1
/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/2
/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/3
/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/1
/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/2
/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/3
/protocolSection/armsInterventionsModule/armGroups/4/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/4/interventionNames/1
/protocolSection/armsInterventionsModule/armGroups/4/interventionNames/2
/protocolSection/armsInterventionsModule/armGroups/4/interventionNames/3
/protocolSection/armsInterventionsModule/armGroups/5/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/5/interventionNames/1
/protocolSection/armsInterventionsModule/armGroups/5/interventionNames/2
/protocolSection/armsInterventionsModule/armGroups/5/interventionNames/3
/protocolSection/armsInterventionsModule/armGroups/6/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/6/interventionNames/1
/protocolSection/armsInterventionsModule/armGroups/6/interventionNames/2
/protocolSection/armsInterventionsModule/armGroups/6/interventionNames/3
/protocolSection/armsInterventionsModule/interventions/0/name
/protocolSection/armsInterventionsModule/interventions/0/description
/protocolSection/armsInterventionsModule/interventions/0/otherNames
/protocolSection/armsInterventionsModule/interventions/1
/protocolSection/armsInterventionsModule/interventions/2
/protocolSection/armsInterventionsModule/interventions/3
/protocolSection/outcomesModule/primaryOutcomes/0/measure
/protocolSection/outcomesModule/primaryOutcomes/1/measure
/protocolSection/outcomesModule/primaryOutcomes/1/description
/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes
/annotationSection
/documentSection/largeDocumentModule/largeDocs/1/uploadDate
/documentSection/largeDocumentModule/largeDocs/1/filename
/documentSection/largeDocumentModule/largeDocs/1/size
/hasResults
/resultsSection
View the field-level diff for before/after values on each changed path.
Deterministic Rules
arms_or_interventions_changeenrollment_count_change Provenance
- Package generation
v0.1.2- Succeeded by
- evt_NCT02229084_v16_v17_bc317e7b2822
- Patch hash
789cb904ff1f6324a6e8dc03fb7fa44b6ff9c645a79f0ab817bb68c4caf1daa1- Canonical hash
a9bc91d7438cc2d66a997a78bf997be65ed36fb031364187da12b3ab73b397c4- Rule set hash
318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86- From snapshot
1b64c904992ddd277d9a9c8ee529682af15960e22230881ab71f824b456b2cc7- To snapshot
70909a794eab1a8f5e457b43ba03450ec7bbc39229c1fc454e7e3c3b2a4f1028- Patch source
- ctgov_internal_history
- Generated at
- 2026-07-31T00:42:12.000Z
- Source URL
- Registry payload
Canonical JSON Preview
Stored payload{
"changed_paths": [
"/protocolSection/statusModule/statusVerifiedDate",
"/protocolSection/statusModule/lastUpdateSubmitDate",
"/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"/protocolSection/statusModule/resultsFirstSubmitDate",
"/protocolSection/statusModule/resultsFirstSubmitQcDate",
"/protocolSection/statusModule/resultsFirstPostDateStruct",
"/protocolSection/descriptionModule/detailedDescription",
"/protocolSection/designModule/enrollmentInfo/count",
"/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0",
"/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1",
"/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2",
"/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/3",
"/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0",
"/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/1",
"/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/2",
"/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/3",
"/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0",
"/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/1",
"/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/2",
"/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/3",
"/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/0",
"/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/1",
"/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/2",
"/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/3",
"/protocolSection/armsInterventionsModule/armGroups/4/interventionNames/0",
"/protocolSection/armsInterventionsModule/armGroups/4/interventionNames/1",
"/protocolSection/armsInterventionsModule/armGroups/4/interventionNames/2",
"/protocolSection/armsInterventionsModule/armGroups/4/interventionNames/3",
"/protocolSection/armsInterventionsModule/armGroups/5/interventionNames/0",
"/protocolSection/armsInterventionsModule/armGroups/5/interventionNames/1",
"/protocolSection/armsInterventionsModule/armGroups/5/interventionNames/2",
"/protocolSection/armsInterventionsModule/armGroups/5/interventionNames/3",
"/protocolSection/armsInterventionsModule/armGroups/6/interventionNames/0",
"/protocolSection/armsInterventionsModule/armGroups/6/interventionNames/1",
"/protocolSection/armsInterventionsModule/armGroups/6/interventionNames/2",
"/protocolSection/armsInterventionsModule/armGroups/6/interventionNames/3",
"/protocolSection/armsInterventionsModule/interventions/0/name",
"/protocolSection/armsInterventionsModule/interventions/0/description",
"/protocolSection/armsInterventionsModule/interventions/0/otherNames",
"/protocolSection/armsInterventionsModule/interventions/1",
"/protocolSection/armsInterventionsModule/interventions/2",
"/protocolSection/armsInterventionsModule/interventions/3",
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"/protocolSection/outcomesModule/primaryOutcomes/1/measure",
"/protocolSection/outcomesModule/primaryOutcomes/1/description",
"/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes",
"/annotationSection",
"/documentSection/largeDocumentModule/largeDocs/1/uploadDate",
"/documentSection/largeDocumentModule/largeDocs/1/filename",
"/documentSection/largeDocumentModule/largeDocs/1/size",
"/hasResults",
"/resultsSection"
],
"citation_text": "TrialDiff Evidence Record evt_NCT02229084_v16_v17_82fce4512999. ClinicalTrials.gov NCT02229084, versions 16-17. 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 16 to version 17 for NCT02229084.",
"The JSON Patch for this comparison has hash 789cb904ff1f6324a6e8dc03fb7fa44b6ff9c645a79f0ab817bb68c4caf1daa1.",
"The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.",
"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 field under an arm or intervention module changed between ClinicalTrials.gov versions 16 and 17.",
"The timing context for the from-version record was post_recruitment.",
"The deterministic rules that fired were: arms_or_interventions_change, enrollment_count_change.",
"The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/descriptionModule/detailedDescription, /protocolSection/designModule/enrollmentInfo/count, /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0, /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1, /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2, /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/3, /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0, /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/1, /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/2, /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/3, /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0, /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/1, /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/2, /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/3, /protocolSection/armsInterventionsModule/armGroups/3/interventionNames/0, /protocolSection/armsInterventionsModule/armGroups/3/interventionNames/1, /protocolSection/armsInterventionsModule/armGroups/3/interventionNames/2, /protocolSection/armsInterventionsModule/armGroups/3/interventionNames/3, /protocolSection/armsInterventionsModule/armGroups/4/interventionNames/0, /protocolSection/armsInterventionsModule/armGroups/4/interventionNames/1, /protocolSection/armsInterventionsModule/armGroups/4/interventionNames/2, /protocolSection/armsInterventionsModule/armGroups/4/interventionNames/3, /protocolSection/armsInterventionsModule/armGroups/5/interventionNames/0, /protocolSection/armsInterventionsModule/armGroups/5/interventionNames/1, /protocolSection/armsInterventionsModule/armGroups/5/interventionNames/2, /protocolSection/armsInterventionsModule/armGroups/5/interventionNames/3, /protocolSection/armsInterventionsModule/armGroups/6/interventionNames/0, /protocolSection/armsInterventionsModule/armGroups/6/interventionNames/1, /protocolSection/armsInterventionsModule/armGroups/6/interventionNames/2, /protocolSection/armsInterventionsModule/armGroups/6/interventionNames/3, /protocolSection/armsInterventionsModule/interventions/0/name, /protocolSection/armsInterventionsModule/interventions/0/description, /protocolSection/armsInterventionsModule/interventions/0/otherNames, /protocolSection/armsInterventionsModule/interventions/1, /protocolSection/armsInterventionsModule/interventions/2, /protocolSection/armsInterventionsModule/interventions/3, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/1/measure, /protocolSection/outcomesModule/primaryOutcomes/1/description, /protocolSection/outcomesModule/primaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes, /annotationSection, /documentSection/largeDocumentModule/largeDocs/1/uploadDate, /documentSection/largeDocumentModule/largeDocs/1/filename, /documentSection/largeDocumentModule/largeDocs/1/size, /hasResults, /resultsSection.",
"An outcome path changed between versions 16 and 17 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
],
"classification": {
"calibration_status": "uncalibrated",
"categories": [
"arm_intervention_change",
"enrollment_change",
"results_reconciliation"
],
"category": "arm_intervention_change",
"deterministic_rules": [
"arms_or_interventions_change",
"enrollment_count_change"
],
"event_class_rule_set_hash": "07957f8b90549d4f42387f51b471ecde9901b6db63bbc27b84c73631603407c0",
"event_classes": [
"outcome_edit_cooccurs_with_results_posting"
],
"rule_set_hash": "318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86",
"severity": "high",
"severity_pre_timing": "high",
"timing_context": "post_recruitment",
"triage_label": "high",
"triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
"value_signals": [
{
"category": "results_reconciliation",
"paths": [
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"/protocolSection/outcomesModule/primaryOutcomes/1/description",
"/protocolSection/outcomesModule/primaryOutcomes/1/measure",
"/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame"
],
"severity": "low",
"signal": "results_reconciliation_outcome_suppression"
}
]
},
"event_id": "evt_NCT02229084_v16_v17_82fce4512999",
"evidence_version": 1,
"patch": [
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2024-04"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2024-04-26"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2024-05-23"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2023-12-20"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2024-04-26"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2024-05-23",
"type": "ACTUAL"
}
},
{
"op": "replace",
"path": "/protocolSection/descriptionModule/detailedDescription",
"value": "<p>The purpose of this study is to evaluate an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with standard neoadjuvant chemotherapy in patients with clinical stage I, II or III estrogen-receptor (ER)-positive, HER2-negative breast cancer.</p><p>This is a single-arm, multi-site Phase I/II study designed with the two goals being (1) to evaluate the feasibility of combining vaccination with the P10s-PADRE formulation with neoadjuvant chemotherapy and (2) to determine if the polymerase chain reaction (pCR) rate among ER-positive, HER2-negativebreast-cancer patients treated with the combination is significantly higher than the 8% rate observed among ER-positive breast-cancer subjects in a pooled analysis of seven randomized clinical trials.\nP10s-PADRE vaccine with MONTANIDE™ ISA 51 VG as adjuvant will be given in combination with neoadjuvant chemotherapy in female patients with clinical stage I, II or III ER-positive, HER2-negative breast cancer.</p><p>This combined Phase I/II feasibility-and-efficacy study will have three parts.\nIts first part will be a Phase I evaluation of the safety, tolerability, and feasibility of eliciting adequate IgG response with P10s-PADRE when administered in combination with SoC neoadjuvant chemotherapy.\nThe study's second and third parts will respectively constitute Stages 1 and 2 of the Phase II primary-efficacy evaluation of Chemovax using a Simon optimal two-stage design</p><p>To evaluate the feasibility of eliciting adequate immune response with P10s-PADRE when it is administered in combination with neoadjuvant chemotherapy, we will sequentially evaluate different schedules of vaccination relative to chemotherapy, and stop evaluating as soon as we have identified a feasible schedule.\nTo this end, we have defined five different Chemovax schedules, and named them A, B, C, D, and E;</p>"
},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/count",
"value": 58
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0",
"value": "Biological: P10s-PADRE/ MONTANIDE™ ISA 51 VG"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1",
"value": "Drug: Doxorubicin"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2",
"value": "Drug: Cyclophosphamide"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/3",
"value": "Drug: Docetaxel"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0",
"value": "Biological: P10s-PADRE/ MONTANIDE™ ISA 51 VG"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/1",
"value": "Drug: Doxorubicin"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/2",
"value": "Drug: Cyclophosphamide"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/3",
"value": "Drug: Docetaxel"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0",
"value": "Biological: P10s-PADRE/ MONTANIDE™ ISA 51 VG"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/1",
"value": "Drug: Doxorubicin"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/2",
"value": "Drug: Cyclophosphamide"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/3",
"value": "Drug: Docetaxel"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/0",
"value": "Biological: P10s-PADRE/ MONTANIDE™ ISA 51 VG"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/1",
"value": "Drug: Doxorubicin"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/2",
"value": "Drug: Cyclophosphamide"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/3",
"value": "Drug: Docetaxel"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/4/interventionNames/0",
"value": "Biological: P10s-PADRE/ MONTANIDE™ ISA 51 VG"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/4/interventionNames/1",
"value": "Drug: Doxorubicin"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/4/interventionNames/2",
"value": "Drug: Cyclophosphamide"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/4/interventionNames/3",
"value": "Drug: Docetaxel"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/5/interventionNames/0",
"value": "Biological: P10s-PADRE/ MONTANIDE™ ISA 51 VG"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/5/interventionNames/1",
"value": "Drug: Doxorubicin"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/5/interventionNames/2",
"value": "Drug: Cyclophosphamide"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/5/interventionNames/3",
"value": "Drug: Docetaxel"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/6/interventionNames/0",
"value": "Biological: P10s-PADRE/ MONTANIDE™ ISA 51 VG"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/6/interventionNames/1",
"value": "Drug: Doxorubicin"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/6/interventionNames/2",
"value": "Drug: Cyclophosphamide"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/6/interventionNames/3",
"value": "Drug: Docetaxel"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/0/name",
"value": "P10s-PADRE/ MONTANIDE™ ISA 51 VG"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/0/description",
"value": "Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions concurrent with chemotherapy."
},
{
"op": "remove",
"path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames"
},
{
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"value": {
"armGroupLabels": [
"Part 1 - Chemovax Schedule A",
"Part 1 - Chemovax Schedule B",
"Part 1 - Chemovax Schedule C",
"Part 1 - Chemovax Schedule D",
"Part 1 - Chemovax Schedule E",
"Part 2 - Chemovax Schedule C",
"Part 3 - Chemovax Schedule C"
],
"description": "Doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) (AC) will be administered concurrently every three weeks for four cycles followed by docetaxel (75 mg/m2) every three weeks for four cycles.",
"name": "Doxorubicin",
"type": "DRUG"
}
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/interventions/2",
"value": {
"armGroupLabels": [
"Part 1 - Chemovax Schedule A",
"Part 1 - Chemovax Schedule B",
"Part 1 - Chemovax Schedule C",
"Part 1 - Chemovax Schedule D",
"Part 1 - Chemovax Schedule E",
"Part 2 - Chemovax Schedule C",
"Part 3 - Chemovax Schedule C"
],
"description": "Doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) (AC) will be administered concurrently every three weeks for four cycles followed by docetaxel (75 mg/m2) every three weeks for four cycles.",
"name": "Cyclophosphamide",
"type": "DRUG"
}
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/interventions/3",
"value": {
"armGroupLabels": [
"Part 1 - Chemovax Schedule A",
"Part 1 - Chemovax Schedule B",
"Part 1 - Chemovax Schedule C",
"Part 1 - Chemovax Schedule D",
"Part 1 - Chemovax Schedule E",
"Part 2 - Chemovax Schedule C",
"Part 3 - Chemovax Schedule C"
],
"description": "<p>Doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) (AC) will be administered concurrently every three weeks for four cycles followed by docetaxel (75 mg/m2) every three weeks for four cycles.</p><p>If docetaxel is not tolerated, paclitaxel (175mg/m2) may be used in its place.</p>",
"name": "Docetaxel",
"type": "DRUG"
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Identify a Feasible Schedule of Vaccination Relative to SoC Neoadjuvant Chemotherapy When the Chemovax Are Administered Concurrently."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
"value": "Determine the pCR Rate"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1/description",
"value": "The patient-level primary outcome for this objective is pCR, which is binary yes/no, and the study-level endpoint for this outcome is the rate of pCR, i.e. the percentage of patients that achieved pCR=yes.\nThe patient is assessed at the time of surgery for whether they achieved pCR=yes.\nThey have to do the surgery in order to obtain the tissue samples on which they do their pCR assessment."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame",
"value": "At the time of definitive surgery (4-8 weeks after chemo, which is between Week 22 and Week 25)"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes",
"value": [
{
"description": "The anti-P10s binding level was measured via ELISA method after incubation with a subject's serum or plasma sample.\nData was collected at multiple timepoints throughout the study.\nValues were averaged for each group.",
"measure": "P10s-MAP-Reactive Immunoglobulin Titers",
"timeFrame": "Week 1 through Week 70"
},
{
"description": "Activated-NK-cell profiles will be determined via flow cytometry as the expression levels of different activation markers on NK cells in the subject's blood sample.\nData was collected at multiple timepoints throughout the study.\nValues were averaged for each group.\nFor some participants, CD16 was not assessable.",
"measure": "Activation Profiles of NK Cells: Pre-Immune and Post-Immune CD16",
"timeFrame": "Week 1 through Week 70"
},
{
"description": "Activated-NK-cell profiles will be determined via flow cytometry as the expression levels of different activation markers on NK cells in the subject's blood sample.\nData was collected at multiple timepoints throughout the study.\nValues were averaged for each group.\nFor some participants, CD69 was not assessable.",
"measure": "Activation Profiles of NK Cells: Pre-Immune and Post-Immune CD69",
"timeFrame": "Week 1 through Week 70"
},
{
"description": "Activated-NK-cell profiles will be determined via flow cytometry as the expression levels of different activation markers on NK cells in the subject's blood sample.\nData was collected at multiple timepoints throughout the study.\nValues were averaged for each group.\nFor some participants, NKp46 was not assessable.",
"measure": "Activation Profiles of NK Cells: Pre-Immune and Post-Immune NKp46",
"timeFrame": "Week 1 through Week 70"
}
]
},
{
"op": "remove",
"path": "/annotationSection"
},
{
"op": "replace",
"path": "/documentSection/largeDocumentModule/largeDocs/1/uploadDate",
"value": "2023-12-20T14:08"
},
{
"op": "replace",
"path": "/documentSection/largeDocumentModule/largeDocs/1/filename",
"value": "ICF_002.pdf"
},
{
"op": "replace",
"path": "/documentSection/largeDocumentModule/largeDocs/1/size",
"value": 425384
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"adverseEventsModule": {
"eventGroups": [
{
"deathsNumAffected": 0,
"deathsNumAtRisk": 5,
"description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "EG000",
"otherNumAffected": 5,
"otherNumAtRisk": 5,
"seriousNumAffected": 4,
"seriousNumAtRisk": 5,
"title": "Part 1 - Chemovax Schedule A"
},
{
"deathsNumAffected": 0,
"deathsNumAtRisk": 5,
"description": "<p>Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "EG001",
"otherNumAffected": 5,
"otherNumAtRisk": 5,
"seriousNumAffected": 4,
"seriousNumAtRisk": 5,
"title": "Part 1 - Chemovax Schedule B"
},
{
"deathsNumAffected": 0,
"deathsNumAtRisk": 5,
"description": "<p>Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "EG002",
"otherNumAffected": 5,
"otherNumAtRisk": 5,
"seriousNumAffected": 3,
"seriousNumAtRisk": 5,
"title": "Part 1 - Chemovax Schedule C"
},
{
"deathsNumAffected": 0,
"deathsNumAtRisk": 5,
"description": "<p>Feasibility - Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "EG003",
"otherNumAffected": 5,
"otherNumAtRisk": 5,
"seriousNumAffected": 1,
"seriousNumAtRisk": 5,
"title": "Part 1 - Chemovax Schedule D"
},
{
"deathsNumAffected": 0,
"deathsNumAtRisk": 5,
"description": "<p>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "EG004",
"otherNumAffected": 5,
"otherNumAtRisk": 5,
"seriousNumAffected": 3,
"seriousNumAtRisk": 5,
"title": "Part 1 - Chemovax Schedule E"
},
{
"deathsNumAffected": 1,
"deathsNumAtRisk": 33,
"description": "<p>Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p><p>The 33 subjects combined from Parts 2 and 3 had the exact same treatment (Schedule C).\nThe final efficacy evaluation required us to combine the pCRs from both parts.</p>",
"id": "EG005",
"otherNumAffected": 33,
"otherNumAtRisk": 33,
"seriousNumAffected": 19,
"seriousNumAtRisk": 33,
"title": "Part 2 & 3 Combined - Chemovax Schedule C"
}
],
"frequencyThreshold": "0",
"otherEvents": [
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 4
},
{
"groupId": "EG001",
"numAffected": 5,
"numAtRisk": 5,
"numEvents": 27
},
{
"groupId": "EG002",
"numAffected": 5,
"numAtRisk": 5,
"numEvents": 11
},
{
"groupId": "EG003",
"numAffected": 3,
"numAtRisk": 5,
"numEvents": 10
},
{
"groupId": "EG004",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 2
},
{
"groupId": "EG005",
"numAffected": 29,
"numAtRisk": 33,
"numEvents": 144
}
],
"term": "Anemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG004",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG005",
"numAffected": 4,
"numAtRisk": 33,
"numEvents": 4
}
],
"term": "Blood and lymphatic system disorders - Other, specify"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 2
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG004",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG005",
"numAffected": 1,
"numAtRisk": 33,
"numEvents": 2
}
],
"term": "Atrial fibrillation"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG004",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG005",
"numAffected": 3,
"numAtRisk": 33,
"numEvents": 3
}
],
"term": "Sinus tachycardia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Ear and labyrinth disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG004",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG005",
"numAffected": 1,
"numAtRisk": 33,
"numEvents": 2
}
],
"term": "Ear and labyrinth disorders - Other, specify"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Ear and labyrinth disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 2,
"numAtRisk": 5,
"numEvents": 2
},
{
"groupId": "EG003",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG004",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG005",
"numAffected": 4,
"numAtRisk": 33,
"numEvents": 4
}
],
"term": "Ear pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Ear and labyrinth disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG004",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG005",
"numAffected": 1,
"numAtRisk": 33,
"numEvents": 3
}
],
"term": "Vertigo"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Endocrine disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG004",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG005",
"numAffected": 5,
"numAtRisk": 33,
"numEvents": 6
}
],
"term": "Hypothyroidism"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Eye disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG004",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG005",
"numAffected": 6,
"numAtRisk": 33,
"numEvents": 7
}
],
"term": "Blurred vision"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Eye disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG004",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG005",
"numAffected": 3,
"numAtRisk": 33,
"numEvents": 5
}
],
"term": "Dry Eye"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Eye disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG004",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG005",
"numAffected": 0,
"numAtRisk": 33,
"numEvents": 0
}
],
"term": "Eye Pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Eye disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG003",
"numAffected": 2,
"numAtRisk": 5,
"numEvents": 2
},
{
"groupId": "EG004",
"numAffected": 2,
"numAtRisk": 5,
"numEvents": 2
},
{
"groupId": "EG005",
"numAffected": 12,
"numAtRisk": 33,
"numEvents": 13
}
],
"term": "Watering eyes"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG004",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG005",
"numAffected": 0,
"numAtRisk": 33,
"numEvents": 0
}
],
"term": "Abdominal distension"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG004",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG005",
"numAffected": 11,
"numAtRisk": 33,
"numEvents": 17
}
],
"term": "Abdominal pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 5,
"numEvents": 4
},
{
"groupId": "EG001",
"numAffected": 2,
"numAtRisk": 5,
"numEvents": 2
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG003",
"numAffected": 4,
"numAtRisk": 5,
"numEvents": 6
},
{
"groupId": "EG004",
"numAffected": 2,
"numAtRisk": 5,
"numEvents": 2
},
{
"groupId": "EG005",
"numAffected": 22,
"numAtRisk": 33,
"numEvents": 34
}
],
"term": "Constipation"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 3,
"numAtRisk": 5,
"numEvents": 3
},
{
"groupId": "EG003",
"numAffected": 3,
"numAtRisk": 5,
"numEvents": 3
},
{
"groupId": "EG004",
"numAffected": 3,
"numAtRisk": 5,
"numEvents": 3
},
{
"groupId": "EG005",
"numAffected": 20,
"numAtRisk": 33,
"numEvents": 30
}
],
"term": "Diarrhea"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
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"groupId": "EG004",
"numAffected": 0,
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{
"groupId": "EG005",
"numAffected": 7,
"numAtRisk": 33,
"numEvents": 8
}
],
"term": "Psychiatric disorders - Other, specify"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Renal and urinary disorders",
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"groupId": "EG000",
"numAffected": 0,
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"groupId": "EG001",
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"groupId": "EG002",
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"numAtRisk": 5,
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},
{
"groupId": "EG005",
"numAffected": 2,
"numAtRisk": 33,
"numEvents": 2
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],
"term": "Hematuria"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Renal and urinary disorders",
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{
"groupId": "EG000",
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"groupId": "EG002",
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"groupId": "EG003",
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"groupId": "EG004",
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"groupId": "EG005",
"numAffected": 2,
"numAtRisk": 33,
"numEvents": 5
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},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Renal and urinary disorders",
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{
"groupId": "EG000",
"numAffected": 0,
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"numEvents": 0
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"groupId": "EG001",
"numAffected": 0,
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"numEvents": 0
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"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
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"groupId": "EG003",
"numAffected": 0,
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"groupId": "EG004",
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{
"groupId": "EG005",
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],
"term": "Renal calculi"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Renal and urinary disorders",
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{
"groupId": "EG000",
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"groupId": "EG001",
"numAffected": 0,
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"groupId": "EG002",
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"groupId": "EG005",
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"numAffected": 0,
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"groupId": "EG005",
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},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Renal and urinary disorders",
"stats": [
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"groupId": "EG000",
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"groupId": "EG005",
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"term": "Urinary urgency"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Reproductive system and breast disorders",
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{
"groupId": "EG000",
"numAffected": 1,
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"groupId": "EG001",
"numAffected": 0,
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"groupId": "EG002",
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"groupId": "EG003",
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"groupId": "EG004",
"numAffected": 2,
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{
"groupId": "EG005",
"numAffected": 9,
"numAtRisk": 33,
"numEvents": 19
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],
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"assessmentType": "SYSTEMATIC_ASSESSMENT",
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{
"groupId": "EG000",
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"groupId": "EG001",
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"groupId": "EG002",
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"groupId": "EG005",
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"assessmentType": "SYSTEMATIC_ASSESSMENT",
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},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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"groupId": "EG001",
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"groupId": "EG004",
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"groupId": "EG005",
"numAffected": 5,
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"numEvents": 6
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],
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},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
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{
"groupId": "EG000",
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"groupId": "EG001",
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"groupId": "EG002",
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"numEvents": 1
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},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"stats": [
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"groupId": "EG000",
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"groupId": "EG001",
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"groupId": "EG005",
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"term": "Nasal congestion"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
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},
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},
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"groupId": "EG005",
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],
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},
{
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{
"groupId": "EG005",
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],
"term": "Sore throat"
},
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"assessmentType": "SYSTEMATIC_ASSESSMENT",
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"stats": [
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"groupId": "EG000",
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"groupId": "EG001",
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"groupId": "EG005",
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],
"term": "Alopecia"
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"groupId": "EG003",
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"groupId": "EG005",
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],
"term": "Dry skin"
},
{
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"groupId": "EG000",
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{
"groupId": "EG005",
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],
"term": "Erythema multifore"
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{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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"groupId": "EG000",
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{
"groupId": "EG005",
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],
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},
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],
"term": "Nail discoloration"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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"stats": [
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"groupId": "EG004",
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},
{
"groupId": "EG005",
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],
"term": "Nail loss"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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"groupId": "EG000",
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{
"groupId": "EG001",
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{
"groupId": "EG005",
"numAffected": 2,
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],
"term": "Pain of skin"
},
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"groupId": "EG000",
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"groupId": "EG005",
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],
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{
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"groupId": "EG000",
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"groupId": "EG001",
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"groupId": "EG005",
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},
{
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"groupId": "EG000",
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"groupId": "EG001",
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},
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"groupId": "EG005",
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],
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},
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"assessmentType": "SYSTEMATIC_ASSESSMENT",
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"groupId": "EG000",
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"groupId": "EG001",
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"groupId": "EG005",
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},
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"groupId": "EG000",
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"groupId": "EG001",
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"groupId": "EG004",
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"groupId": "EG005",
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}
],
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},
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"groupId": "EG000",
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"groupId": "EG001",
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"groupId": "EG003",
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"groupId": "EG004",
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{
"groupId": "EG005",
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}
],
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},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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"groupId": "EG000",
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{
"groupId": "EG001",
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{
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"groupId": "EG004",
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{
"groupId": "EG005",
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],
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},
{
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"groupId": "EG000",
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{
"groupId": "EG001",
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{
"groupId": "EG002",
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"groupId": "EG003",
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],
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},
{
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"groupId": "EG000",
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},
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],
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},
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"groupId": "EG000",
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"groupId": "EG001",
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{
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"groupId": "EG003",
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{
"groupId": "EG005",
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}
],
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},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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"groupId": "EG000",
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}
],
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},
{
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"groupId": "EG000",
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{
"groupId": "EG005",
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],
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},
{
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"groupId": "EG000",
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}
],
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},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Ear and labyrinth disorders",
"stats": [
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"groupId": "EG000",
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{
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"groupId": "EG005",
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],
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},
{
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"groupId": "EG000",
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"groupId": "EG002",
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"groupId": "EG003",
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"groupId": "EG004",
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"groupId": "EG005",
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],
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},
{
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"groupId": "EG002",
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"groupId": "EG003",
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"groupId": "EG004",
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],
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},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Eye disorders",
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"groupId": "EG000",
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{
"groupId": "EG001",
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"groupId": "EG002",
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"groupId": "EG003",
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"groupId": "EG004",
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"groupId": "EG005",
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],
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},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Eye disorders",
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"groupId": "EG000",
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{
"groupId": "EG001",
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{
"groupId": "EG002",
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{
"groupId": "EG003",
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{
"groupId": "EG004",
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"groupId": "EG005",
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],
"term": "Conjunctivitis"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Eye disorders",
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"groupId": "EG000",
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{
"groupId": "EG001",
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},
{
"groupId": "EG002",
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{
"groupId": "EG003",
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{
"groupId": "EG004",
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{
"groupId": "EG005",
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}
],
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},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Eye disorders",
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"groupId": "EG000",
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{
"groupId": "EG001",
"numAffected": 0,
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},
{
"groupId": "EG002",
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{
"groupId": "EG003",
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{
"groupId": "EG004",
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},
{
"groupId": "EG005",
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}
],
"term": "Glaucoma"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Eye disorders",
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"groupId": "EG000",
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{
"groupId": "EG001",
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},
{
"groupId": "EG002",
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{
"groupId": "EG003",
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},
{
"groupId": "EG004",
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},
{
"groupId": "EG005",
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}
],
"term": "Optic nerve disorder"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Eye disorders",
"stats": [
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"groupId": "EG000",
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},
{
"groupId": "EG001",
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{
"groupId": "EG002",
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{
"groupId": "EG003",
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"groupId": "EG004",
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{
"groupId": "EG005",
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}
],
"term": "Photophobia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Eye disorders",
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"groupId": "EG000",
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{
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"groupId": "EG002",
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"groupId": "EG003",
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{
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],
"term": "Eye disorders - Other, specify"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
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"term": "Edema limbs"
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],
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{
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],
"term": "Atelectasis"
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{
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},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG004",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG005",
"numAffected": 1,
"numAtRisk": 33,
"numEvents": 1
}
],
"term": "Pulmonary edema"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG004",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG005",
"numAffected": 1,
"numAtRisk": 33,
"numEvents": 1
}
],
"term": "Rash maculo-papular"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Surgical and medical procedures",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG004",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG005",
"numAffected": 1,
"numAtRisk": 33,
"numEvents": 4
}
],
"term": "Surgical and medical procedures - Other, specify"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Vascular disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG004",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG005",
"numAffected": 1,
"numAtRisk": 33,
"numEvents": 1
}
],
"term": "Hypotension"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Vascular disorders",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG004",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG005",
"numAffected": 1,
"numAtRisk": 33,
"numEvents": 1
}
],
"term": "Vascular disorders - Other, specify"
}
],
"timeFrame": "Adverse events were collected from the time of consent through the duration of the study, which is approximately 16 months after the first vaccination."
},
"baselineCharacteristicsModule": {
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "19"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "58"
}
],
"units": "Participants"
}
],
"groups": [
{
"description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "BG000",
"title": "Part 1 - Chemovax Schedule A"
},
{
"description": "<p>Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "BG001",
"title": "Part 1 - Chemovax Schedule B"
},
{
"description": "<p>Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "BG002",
"title": "Part 1 - Chemovax Schedule C"
},
{
"description": "<p>Feasibility - Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "BG003",
"title": "Part 1 - Chemovax Schedule D"
},
{
"description": "<p>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "BG004",
"title": "Part 1 - Chemovax Schedule E"
},
{
"description": "<p>Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "BG005",
"title": "Part 2 - Chemovax Schedule C"
},
{
"description": "<p>Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25)..</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "BG006",
"title": "Part 3 - Chemovax Schedule C"
},
{
"description": "Total of all reporting groups",
"id": "BG007",
"title": "Total"
}
],
"measures": [
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
},
{
"groupId": "BG003",
"value": "0"
},
{
"groupId": "BG004",
"value": "0"
},
{
"groupId": "BG005",
"value": "0"
},
{
"groupId": "BG006",
"value": "0"
},
{
"groupId": "BG007",
"value": "0"
}
],
"title": "<=18 years"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "4"
},
{
"groupId": "BG001",
"value": "4"
},
{
"groupId": "BG002",
"value": "4"
},
{
"groupId": "BG003",
"value": "3"
},
{
"groupId": "BG004",
"value": "4"
},
{
"groupId": "BG005",
"value": "17"
},
{
"groupId": "BG006",
"value": "13"
},
{
"groupId": "BG007",
"value": "49"
}
],
"title": "Between 18 and 65 years"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "1"
},
{
"groupId": "BG001",
"value": "1"
},
{
"groupId": "BG002",
"value": "1"
},
{
"groupId": "BG003",
"value": "2"
},
{
"groupId": "BG004",
"value": "1"
},
{
"groupId": "BG005",
"value": "2"
},
{
"groupId": "BG006",
"value": "1"
},
{
"groupId": "BG007",
"value": "9"
}
],
"title": ">=65 years"
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "19"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "58"
}
],
"units": "Participants"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Age, Categorical",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"spread": "12.37",
"value": "59"
},
{
"groupId": "BG001",
"spread": "10.2",
"value": "53"
},
{
"groupId": "BG002",
"spread": "11.69",
"value": "57.6"
},
{
"groupId": "BG003",
"spread": "15.42",
"value": "54.8"
},
{
"groupId": "BG004",
"spread": "15.24",
"value": "43.4"
},
{
"groupId": "BG005",
"spread": "10.73",
"value": "52.58"
},
{
"groupId": "BG006",
"spread": "10.73",
"value": "46.86"
},
{
"groupId": "BG007",
"spread": "10.94",
"value": "50.15"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "19"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "58"
}
],
"units": "Participants"
}
]
}
],
"dispersionType": "STANDARD_DEVIATION",
"paramType": "MEAN",
"title": "Age, Continuous",
"unitOfMeasure": "years"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "19"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "58"
}
],
"title": "Female"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
},
{
"groupId": "BG003",
"value": "0"
},
{
"groupId": "BG004",
"value": "0"
},
{
"groupId": "BG005",
"value": "0"
},
{
"groupId": "BG006",
"value": "0"
},
{
"groupId": "BG007",
"value": "0"
}
],
"title": "Male"
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "19"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "58"
}
],
"units": "Participants"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Sex: Female, Male",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
},
{
"groupId": "BG003",
"value": "0"
},
{
"groupId": "BG004",
"value": "0"
},
{
"groupId": "BG005",
"value": "0"
},
{
"groupId": "BG006",
"value": "2"
},
{
"groupId": "BG007",
"value": "2"
}
],
"title": "Hispanic or Latino"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
},
{
"groupId": "BG003",
"value": "0"
},
{
"groupId": "BG004",
"value": "0"
},
{
"groupId": "BG005",
"value": "10"
},
{
"groupId": "BG006",
"value": "6"
},
{
"groupId": "BG007",
"value": "16"
}
],
"title": "Not Hispanic or Latino"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "9"
},
{
"groupId": "BG006",
"value": "6"
},
{
"groupId": "BG007",
"value": "40"
}
],
"title": "Unknown or Not Reported"
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "19"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "58"
}
],
"units": "Participants"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Ethnicity (NIH/OMB)",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
},
{
"groupId": "BG003",
"value": "0"
},
{
"groupId": "BG004",
"value": "0"
},
{
"groupId": "BG005",
"value": "0"
},
{
"groupId": "BG006",
"value": "0"
},
{
"groupId": "BG007",
"value": "0"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "19"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "58"
}
],
"units": "Participants"
}
],
"title": "American Indian or Alaska Native"
},
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "1"
},
{
"groupId": "BG002",
"value": "0"
},
{
"groupId": "BG003",
"value": "0"
},
{
"groupId": "BG004",
"value": "0"
},
{
"groupId": "BG005",
"value": "0"
},
{
"groupId": "BG006",
"value": "1"
},
{
"groupId": "BG007",
"value": "2"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "19"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "58"
}
],
"units": "Participants"
}
],
"title": "Asian"
},
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
},
{
"groupId": "BG003",
"value": "0"
},
{
"groupId": "BG004",
"value": "0"
},
{
"groupId": "BG005",
"value": "0"
},
{
"groupId": "BG006",
"value": "0"
},
{
"groupId": "BG007",
"value": "0"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "19"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "58"
}
],
"units": "Participants"
}
],
"title": "Native Hawaiian or Pacific Islander"
},
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "1"
},
{
"groupId": "BG002",
"value": "0"
},
{
"groupId": "BG003",
"value": "0"
},
{
"groupId": "BG004",
"value": "0"
},
{
"groupId": "BG005",
"value": "5"
},
{
"groupId": "BG006",
"value": "3"
},
{
"groupId": "BG007",
"value": "9"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "19"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "58"
}
],
"units": "Participants"
}
],
"title": "Black or African American"
},
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "3"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "14"
},
{
"groupId": "BG006",
"value": "8"
},
{
"groupId": "BG007",
"value": "45"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "19"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "58"
}
],
"units": "Participants"
}
],
"title": "White"
},
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
},
{
"groupId": "BG003",
"value": "0"
},
{
"groupId": "BG004",
"value": "0"
},
{
"groupId": "BG005",
"value": "0"
},
{
"groupId": "BG006",
"value": "2"
},
{
"groupId": "BG007",
"value": "2"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "19"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "58"
}
],
"units": "Participants"
}
],
"title": "Other"
},
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
},
{
"groupId": "BG003",
"value": "0"
},
{
"groupId": "BG004",
"value": "0"
},
{
"groupId": "BG005",
"value": "0"
},
{
"groupId": "BG006",
"value": "0"
},
{
"groupId": "BG007",
"value": "0"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "19"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "58"
}
],
"units": "Participants"
}
],
"title": "More than one race"
},
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
},
{
"groupId": "BG003",
"value": "0"
},
{
"groupId": "BG004",
"value": "0"
},
{
"groupId": "BG005",
"value": "0"
},
{
"groupId": "BG006",
"value": "0"
},
{
"groupId": "BG007",
"value": "0"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "19"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "58"
}
],
"units": "Participants"
}
],
"title": "Unknown or Not Reported"
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Race/Ethnicity, Customized",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "2"
},
{
"groupId": "BG003",
"value": "1"
},
{
"groupId": "BG004",
"value": "0"
},
{
"groupId": "BG005",
"value": "10"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "37"
}
],
"title": "Central Arkansas at University of Arkansas for Medical Sciences"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "3"
},
{
"groupId": "BG003",
"value": "4"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "9"
},
{
"groupId": "BG006",
"value": "0"
},
{
"groupId": "BG007",
"value": "21"
}
],
"title": "Northwest Arkansas at Highlands Oncology Group"
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "19"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "58"
}
],
"units": "Participants"
}
],
"title": "United States"
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Region of Enrollment",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "4"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "4"
},
{
"groupId": "BG004",
"value": "4"
},
{
"groupId": "BG005",
"value": "18"
},
{
"groupId": "BG006",
"value": "13"
},
{
"groupId": "BG007",
"value": "53"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "19"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "58"
}
],
"units": "Participants"
}
],
"title": "0 Fully active, able to carry on all pre-disease"
},
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "1"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
},
{
"groupId": "BG003",
"value": "1"
},
{
"groupId": "BG004",
"value": "1"
},
{
"groupId": "BG005",
"value": "1"
},
{
"groupId": "BG006",
"value": "1"
},
{
"groupId": "BG007",
"value": "5"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "19"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "58"
}
],
"units": "Participants"
}
],
"title": "1 Restricted in physically strenuous activity but ambulatory and able to carry out work"
}
],
"description": "Measure of how cancer affects a person's day-to-day life (https://ecog-acrin.org/resources/ecog-performance-status/).\nIn this study, having a score of 0-1 was a criterion for eligibility.",
"paramType": "COUNT_OF_PARTICIPANTS",
"populationDescription": "For 1 participant in Part 2, ECOG Performance was not given.",
"title": "Eastern Cooperative Oncology Group (ECOG) Performance Status",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"spread": ".84",
"value": "2.9"
},
{
"groupId": "BG001",
"spread": "1.44",
"value": "4.06"
},
{
"groupId": "BG002",
"spread": "2.03",
"value": "4.82"
},
{
"groupId": "BG003",
"spread": "2.56",
"value": "3.76"
},
{
"groupId": "BG004",
"spread": "0.82",
"value": "1.96"
},
{
"groupId": "BG005",
"spread": "2.67",
"value": "4.13"
},
{
"groupId": "BG006",
"spread": "2.19",
"value": "5.43"
},
{
"groupId": "BG007",
"spread": "2.38",
"value": "4.03"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "19"
},
{
"groupId": "BG006",
"value": "13"
},
{
"groupId": "BG007",
"value": "57"
}
],
"units": "Participants"
}
]
}
],
"description": "Length of longest diameter of tumor measured in centimeters.",
"dispersionType": "STANDARD_DEVIATION",
"paramType": "MEAN",
"populationDescription": "For 1 participant in Part 3, pre-treatment tumor size was not reported.",
"title": "Pre-Treatment Tumor Size",
"unitOfMeasure": "centimeters"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
},
{
"groupId": "BG003",
"value": "1"
},
{
"groupId": "BG004",
"value": "1"
},
{
"groupId": "BG005",
"value": "2"
},
{
"groupId": "BG006",
"value": "0"
},
{
"groupId": "BG007",
"value": "4"
}
],
"title": "Stage IA"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
},
{
"groupId": "BG003",
"value": "0"
},
{
"groupId": "BG004",
"value": "0"
},
{
"groupId": "BG005",
"value": "0"
},
{
"groupId": "BG006",
"value": "1"
},
{
"groupId": "BG007",
"value": "1"
}
],
"title": "Stage IB"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
},
{
"groupId": "BG003",
"value": "1"
},
{
"groupId": "BG004",
"value": "0"
},
{
"groupId": "BG005",
"value": "1"
},
{
"groupId": "BG006",
"value": "3"
},
{
"groupId": "BG007",
"value": "5"
}
],
"title": "Stage II"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "1"
},
{
"groupId": "BG001",
"value": "2"
},
{
"groupId": "BG002",
"value": "0"
},
{
"groupId": "BG003",
"value": "1"
},
{
"groupId": "BG004",
"value": "1"
},
{
"groupId": "BG005",
"value": "4"
},
{
"groupId": "BG006",
"value": "2"
},
{
"groupId": "BG007",
"value": "11"
}
],
"title": "Stage IIA"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "3"
},
{
"groupId": "BG001",
"value": "1"
},
{
"groupId": "BG002",
"value": "2"
},
{
"groupId": "BG003",
"value": "1"
},
{
"groupId": "BG004",
"value": "2"
},
{
"groupId": "BG005",
"value": "4"
},
{
"groupId": "BG006",
"value": "4"
},
{
"groupId": "BG007",
"value": "17"
}
],
"title": "Stage IIB"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
},
{
"groupId": "BG003",
"value": "1"
},
{
"groupId": "BG004",
"value": "0"
},
{
"groupId": "BG005",
"value": "3"
},
{
"groupId": "BG006",
"value": "2"
},
{
"groupId": "BG007",
"value": "6"
}
],
"title": "Stage III"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "1"
},
{
"groupId": "BG002",
"value": "0"
},
{
"groupId": "BG003",
"value": "0"
},
{
"groupId": "BG004",
"value": "0"
},
{
"groupId": "BG005",
"value": "2"
},
{
"groupId": "BG006",
"value": "1"
},
{
"groupId": "BG007",
"value": "4"
}
],
"title": "Stage IIIA"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "1"
},
{
"groupId": "BG001",
"value": "1"
},
{
"groupId": "BG002",
"value": "2"
},
{
"groupId": "BG003",
"value": "0"
},
{
"groupId": "BG004",
"value": "1"
},
{
"groupId": "BG005",
"value": "2"
},
{
"groupId": "BG006",
"value": "1"
},
{
"groupId": "BG007",
"value": "8"
}
],
"title": "Stage IIIB"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "1"
},
{
"groupId": "BG003",
"value": "0"
},
{
"groupId": "BG004",
"value": "0"
},
{
"groupId": "BG005",
"value": "0"
},
{
"groupId": "BG006",
"value": "0"
},
{
"groupId": "BG007",
"value": "1"
}
],
"title": "Stage not reported/given"
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "18"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "57"
}
],
"units": "Participants"
}
]
}
],
"description": "<p>Participants had their tumors surgically removed and pathologically staged using the AJCC Staging criteria.</p><p>Stage 1 breast cancer means that the cancer is small and only in the breast tissue or it might be found in lymph nodes close to the breast.</p><p>Stage 2 breast cancer means that the cancer is either in the breast or in the nearby lymph nodes or both.</p><p>Stage 3 means that the cancer has spread from the breast to the lymph nodes close to the breast, to the skin of the breast or to the chest wall.</p><p>Stage 4 breast cancer has spread to another part of the body.</p>",
"paramType": "COUNT_OF_PARTICIPANTS",
"populationDescription": "For 2 participants, both in Part 2, AJCC stage was not given.",
"title": "American Joint Committee on Cancer (AJCC) Tumor Staging",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "1"
},
{
"groupId": "BG003",
"value": "0"
},
{
"groupId": "BG004",
"value": "0"
},
{
"groupId": "BG005",
"value": "2"
},
{
"groupId": "BG006",
"value": "3"
},
{
"groupId": "BG007",
"value": "6"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "19"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "58"
}
],
"units": "Participants"
}
],
"title": "Grade I"
},
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "2"
},
{
"groupId": "BG001",
"value": "4"
},
{
"groupId": "BG002",
"value": "2"
},
{
"groupId": "BG003",
"value": "3"
},
{
"groupId": "BG004",
"value": "2"
},
{
"groupId": "BG005",
"value": "9"
},
{
"groupId": "BG006",
"value": "4"
},
{
"groupId": "BG007",
"value": "26"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "19"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "58"
}
],
"units": "Participants"
}
],
"title": "Grade II"
},
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "3"
},
{
"groupId": "BG001",
"value": "1"
},
{
"groupId": "BG002",
"value": "2"
},
{
"groupId": "BG003",
"value": "2"
},
{
"groupId": "BG004",
"value": "3"
},
{
"groupId": "BG005",
"value": "8"
},
{
"groupId": "BG006",
"value": "6"
},
{
"groupId": "BG007",
"value": "25"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "19"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "58"
}
],
"units": "Participants"
}
],
"title": "Grade III"
},
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
},
{
"groupId": "BG003",
"value": "0"
},
{
"groupId": "BG004",
"value": "0"
},
{
"groupId": "BG005",
"value": "0"
},
{
"groupId": "BG006",
"value": "1"
},
{
"groupId": "BG007",
"value": "1"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "19"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "58"
}
],
"units": "Participants"
}
],
"title": "Grade X (Unknown)"
}
],
"description": "<p>Participants had their tumors surgically removed and based off microscopic appearance of abnormality in cells, tumor was pathologically graded with the classifications Grade 1 (or well differentiated) means the cells are slower-growing, and look more like normal breast cells.</p><p>Grade 2 (or moderately differentiated) means the cells are growing at a speed of and look like cells somewhere between grades 1 and 3.</p><p>Grade 3 (poorly differentiated) means the cancer cells look very different from normal cells and will probably grow and spread faster.</p><p>Grad X means the cancer cells cannot be assessed.</p>",
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Tumor Grade",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "2"
},
{
"groupId": "BG001",
"value": "4"
},
{
"groupId": "BG002",
"value": "3"
},
{
"groupId": "BG003",
"value": "2"
},
{
"groupId": "BG004",
"value": "1"
},
{
"groupId": "BG005",
"value": "0"
},
{
"groupId": "BG006",
"value": "0"
},
{
"groupId": "BG007",
"value": "12"
}
],
"title": "Luminal A"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "3"
},
{
"groupId": "BG001",
"value": "1"
},
{
"groupId": "BG002",
"value": "2"
},
{
"groupId": "BG003",
"value": "3"
},
{
"groupId": "BG004",
"value": "4"
},
{
"groupId": "BG005",
"value": "0"
},
{
"groupId": "BG006",
"value": "0"
},
{
"groupId": "BG007",
"value": "13"
}
],
"title": "Luminal B"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
},
{
"groupId": "BG003",
"value": "0"
},
{
"groupId": "BG004",
"value": "0"
},
{
"groupId": "BG005",
"value": "19"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "33"
}
],
"title": "Not collected"
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "5"
},
{
"groupId": "BG002",
"value": "5"
},
{
"groupId": "BG003",
"value": "5"
},
{
"groupId": "BG004",
"value": "5"
},
{
"groupId": "BG005",
"value": "19"
},
{
"groupId": "BG006",
"value": "14"
},
{
"groupId": "BG007",
"value": "58"
}
],
"units": "Participants"
}
]
}
],
"description": "Luminal A or B tumor type",
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Tumor Type",
"unitOfMeasure": "Participants"
}
]
},
"moreInfoModule": {
"certainAgreement": {
"piSponsorEmployee": true
},
"pointOfContact": {
"email": "SBLo@uams.edu",
"organization": "University of Arkansas for Medical Sciences",
"phone": "5016868274",
"title": "Sorena Lo"
}
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "3"
},
{
"groupId": "OG001",
"value": "2"
},
{
"groupId": "OG002",
"value": "4"
},
{
"groupId": "OG003",
"value": "2"
},
{
"groupId": "OG004",
"value": "4"
}
],
"title": "Greater than or equal to 4-fold increase"
},
{
"measurements": [
{
"groupId": "OG000",
"value": "2"
},
{
"groupId": "OG001",
"value": "3"
},
{
"groupId": "OG002",
"value": "1"
},
{
"groupId": "OG003",
"value": "3"
},
{
"groupId": "OG004",
"value": "1"
}
],
"title": "Less than 4-fold increase"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "5"
},
{
"groupId": "OG001",
"value": "5"
},
{
"groupId": "OG002",
"value": "5"
},
{
"groupId": "OG003",
"value": "5"
},
{
"groupId": "OG004",
"value": "5"
}
],
"units": "Participants"
}
],
"description": "<p>Number of participants with sufficiently high anti-P10s immunoglobulin-G response Feasibility will be evaluated in terms of</p><ol><li>Generation of a sufficiently high anti-P10s immunoglobulin-G response</li><li>Safety and tolerability of the combination of vaccine and chemotherapy</li></ol>",
"groups": [
{
"description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG000",
"title": "Part 1 - Chemovax Schedule A"
},
{
"description": "<p>Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG001",
"title": "Part 1 - Chemovax Schedule B"
},
{
"description": "<p>Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG002",
"title": "Part 1 - Chemovax Schedule C"
},
{
"description": "<p>Feasibility - Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG003",
"title": "Part 1 - Chemovax Schedule D"
},
{
"description": "<p>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG004",
"title": "Part 1 - Chemovax Schedule E"
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"populationDescription": "This was defined as a >4-fold increase in a subject's anti-P10s-MAP IgG titer at Week 7 or later (at least 4 weeks after the 3rd immunization) relative to her pre-immune titer.\nFor 1 participant, the Week 7 antibody titer was NA.",
"reportingStatus": "POSTED",
"timeFrame": "At the time of definitive surgery (4-8 weeks after chemo, which is between Week 22 and Week 25)",
"title": "Identify a Feasible Schedule of Vaccination Relative to SoC Neoadjuvant Chemotherapy When the Chemovax Are Administered Concurrently.",
"type": "PRIMARY",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0"
},
{
"groupId": "OG001",
"value": "0"
},
{
"groupId": "OG002",
"value": "0"
},
{
"groupId": "OG003",
"value": "0"
},
{
"groupId": "OG004",
"value": "0"
},
{
"groupId": "OG005",
"value": "3"
},
{
"groupId": "OG006",
"value": "1"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "0"
},
{
"groupId": "OG001",
"value": "0"
},
{
"groupId": "OG002",
"value": "0"
},
{
"groupId": "OG003",
"value": "0"
},
{
"groupId": "OG004",
"value": "0"
},
{
"groupId": "OG005",
"value": "19"
},
{
"groupId": "OG006",
"value": "14"
}
],
"units": "Participants"
}
],
"description": "The patient-level primary outcome for this objective is pCR, which is binary yes/no, and the study-level endpoint for this outcome is the rate of pCR, i.e. the percentage of patients that achieved pCR=yes.\nThe patient is assessed at the time of surgery for whether they achieved pCR=yes.\nThey have to do the surgery in order to obtain the tissue samples on which they do their pCR assessment.",
"groups": [
{
"description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG000",
"title": "Part 1 - Chemovax Schedule A"
},
{
"description": "<p>Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG001",
"title": "Part 1 - Chemovax Schedule B"
},
{
"description": "<p>Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG002",
"title": "Part 1 - Chemovax Schedule C"
},
{
"description": "<p>Feasibility - Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG003",
"title": "Part 1 - Chemovax Schedule D"
},
{
"description": "<p>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG004",
"title": "Part 1 - Chemovax Schedule E"
},
{
"description": "<p>Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG005",
"title": "Part 2 - Chemovax Schedule C"
},
{
"description": "<p>Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25)..</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG006",
"title": "Part 3 - Chemovax Schedule C"
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"populationDescription": "Clinical Response was determined for participants in Part 2 and 3. Part 2 Chemovax Schedule C was Stage 1 of the Simon 2-stage design.\nStage 1's efficacy decision was a rule-based decision.\nIf Stage 1 had 2 or more pCRs, then we could open up Stage 2 and start enrolling patients on it.\nPart 3 Chemovax Schedule C was Stage 2 of the Simon 2-stage design.\nIt was supposed to enroll 22 subjects, but it had enrolled only 14 subjects by the time the study was closed to enrollment.",
"reportingStatus": "POSTED",
"timeFrame": "At the time of definitive surgery (4-8 weeks after chemo, which is between Week 22 and Week 25)",
"title": "Determine the pCR Rate",
"type": "PRIMARY",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"spread": "14.97",
"value": "10.72"
},
{
"groupId": "OG001",
"spread": "13.91",
"value": "9.76"
},
{
"groupId": "OG002",
"spread": "71.94",
"value": "42.25"
},
{
"groupId": "OG003",
"spread": "5.10",
"value": "4.38"
},
{
"groupId": "OG004",
"spread": "7",
"value": "6.74"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "5"
},
{
"groupId": "OG001",
"value": "5"
},
{
"groupId": "OG002",
"value": "5"
},
{
"groupId": "OG003",
"value": "5"
},
{
"groupId": "OG004",
"value": "5"
}
],
"units": "Participants"
}
],
"description": "The anti-P10s binding level was measured via ELISA method after incubation with a subject's serum or plasma sample.\nData was collected at multiple timepoints throughout the study.\nValues were averaged for each group.",
"dispersionType": "Standard Deviation",
"groups": [
{
"description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG000",
"title": "Part 1 - Chemovax Schedule A"
},
{
"description": "<p>Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG001",
"title": "Part 1 - Chemovax Schedule B"
},
{
"description": "<p>Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG002",
"title": "Part 1 - Chemovax Schedule C"
},
{
"description": "<p>Feasibility - Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG003",
"title": "Part 1 - Chemovax Schedule D"
},
{
"description": "<p>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG004",
"title": "Part 1 - Chemovax Schedule E"
}
],
"paramType": "MEAN",
"reportingStatus": "POSTED",
"timeFrame": "Week 1 through Week 70",
"title": "P10s-MAP-Reactive Immunoglobulin Titers",
"type": "SECONDARY",
"unitOfMeasure": "titers"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"spread": "7976.46",
"value": "26065"
},
{
"groupId": "OG001",
"spread": "2261.51",
"value": "26580"
},
{
"groupId": "OG002",
"spread": "6493",
"value": "25171.8"
},
{
"groupId": "OG003",
"spread": "7197.16",
"value": "28546"
},
{
"groupId": "OG004",
"spread": "5334.72",
"value": "24897"
},
{
"groupId": "OG005",
"spread": "31389.28",
"value": "67445.83"
},
{
"groupId": "OG006",
"spread": "27944.66",
"value": "68619.59"
}
]
}
],
"title": "Pre-Immune CD16"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"spread": "5182.72",
"value": "19745.4"
},
{
"groupId": "OG001",
"spread": "7061.48",
"value": "20993.4"
},
{
"groupId": "OG002",
"spread": "10142.41",
"value": "27998.6"
},
{
"groupId": "OG003",
"spread": "6020.06",
"value": "22959.8"
},
{
"groupId": "OG004",
"spread": "20572.69",
"value": "25711.75"
},
{
"groupId": "OG005",
"spread": "24021.75",
"value": "62323.05"
},
{
"groupId": "OG006",
"spread": "24645.52",
"value": "65410.12"
}
]
}
],
"title": "Post-Immune CD16"
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "5"
},
{
"groupId": "OG001",
"value": "5"
},
{
"groupId": "OG002",
"value": "5"
},
{
"groupId": "OG003",
"value": "5"
},
{
"groupId": "OG004",
"value": "4"
},
{
"groupId": "OG005",
"value": "19"
},
{
"groupId": "OG006",
"value": "14"
}
],
"units": "Participants"
}
],
"description": "Activated-NK-cell profiles will be determined via flow cytometry as the expression levels of different activation markers on NK cells in the subject's blood sample.\nData was collected at multiple timepoints throughout the study.\nValues were averaged for each group.\nFor some participants, CD16 was not assessable.",
"dispersionType": "Standard Deviation",
"groups": [
{
"description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG000",
"title": "Part 1 - Chemovax Schedule A"
},
{
"description": "<p>Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG001",
"title": "Part 1 - Chemovax Schedule B"
},
{
"description": "<p>Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG002",
"title": "Part 1 - Chemovax Schedule C"
},
{
"description": "<p>Feasibility - Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG003",
"title": "Part 1 - Chemovax Schedule D"
},
{
"description": "<p>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG004",
"title": "Part 1 - Chemovax Schedule E"
},
{
"description": "<p>Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG005",
"title": "Part 2 - Chemovax Schedule C"
},
{
"description": "<p>Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25)..</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG006",
"title": "Part 3 - Chemovax Schedule C"
}
],
"paramType": "MEAN",
"reportingStatus": "POSTED",
"timeFrame": "Week 1 through Week 70",
"title": "Activation Profiles of NK Cells: Pre-Immune and Post-Immune CD16",
"type": "SECONDARY",
"unitOfMeasure": "Median Fluorescence Intensity (MFI)"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"spread": "50.08",
"value": "268.2"
},
{
"groupId": "OG001",
"spread": "88.02",
"value": "300.8"
},
{
"groupId": "OG002",
"spread": "38.55",
"value": "291.4"
},
{
"groupId": "OG003",
"spread": "57.27",
"value": "294.6"
},
{
"groupId": "OG004",
"spread": "34.37",
"value": "296.25"
},
{
"groupId": "OG005",
"spread": "133",
"value": "428"
},
{
"groupId": "OG006",
"spread": "169.17",
"value": "445.5"
}
]
}
],
"title": "Pre-Immune CD69"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"spread": "72.29",
"value": "307"
},
{
"groupId": "OG001",
"spread": "26.23",
"value": "329.6"
},
{
"groupId": "OG002",
"spread": "25.25",
"value": "275"
},
{
"groupId": "OG003",
"spread": "27.87",
"value": "278.4"
},
{
"groupId": "OG004",
"spread": "16.76",
"value": "311.25"
},
{
"groupId": "OG005",
"spread": "139.9",
"value": "489.44"
},
{
"groupId": "OG006",
"spread": "161.11",
"value": "505.97"
}
]
}
],
"title": "Post-Immune CD69"
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "5"
},
{
"groupId": "OG001",
"value": "5"
},
{
"groupId": "OG002",
"value": "5"
},
{
"groupId": "OG003",
"value": "5"
},
{
"groupId": "OG004",
"value": "4"
},
{
"groupId": "OG005",
"value": "19"
},
{
"groupId": "OG006",
"value": "14"
}
],
"units": "Participants"
}
],
"description": "Activated-NK-cell profiles will be determined via flow cytometry as the expression levels of different activation markers on NK cells in the subject's blood sample.\nData was collected at multiple timepoints throughout the study.\nValues were averaged for each group.\nFor some participants, CD69 was not assessable.",
"dispersionType": "Standard Deviation",
"groups": [
{
"description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG000",
"title": "Part 1 - Chemovax Schedule A"
},
{
"description": "<p>Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG001",
"title": "Part 1 - Chemovax Schedule B"
},
{
"description": "<p>Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG002",
"title": "Part 1 - Chemovax Schedule C"
},
{
"description": "<p>Feasibility - Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG003",
"title": "Part 1 - Chemovax Schedule D"
},
{
"description": "<p>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG004",
"title": "Part 1 - Chemovax Schedule E"
},
{
"description": "<p>Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG005",
"title": "Part 2 - Chemovax Schedule C"
},
{
"description": "<p>Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25)..</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG006",
"title": "Part 3 - Chemovax Schedule C"
}
],
"paramType": "MEAN",
"reportingStatus": "POSTED",
"timeFrame": "Week 1 through Week 70",
"title": "Activation Profiles of NK Cells: Pre-Immune and Post-Immune CD69",
"type": "SECONDARY",
"unitOfMeasure": "Median Fluorescence Intensity (MFI)"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"spread": "390.469",
"value": "685.2"
},
{
"groupId": "OG001",
"spread": "204.147",
"value": "590.4"
},
{
"groupId": "OG002",
"spread": "422.436",
"value": "724.2"
},
{
"groupId": "OG003",
"spread": "355.618",
"value": "794.2"
},
{
"groupId": "OG004",
"spread": "251.998",
"value": "744.25"
},
{
"groupId": "OG005",
"spread": "638.97",
"value": "1360.33"
},
{
"groupId": "OG006",
"spread": "878.64",
"value": "1650.08"
}
]
}
],
"title": "Pre-Immune NKp46"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"spread": "489.819",
"value": "1391"
},
{
"groupId": "OG001",
"spread": "485.348",
"value": "1115.6"
},
{
"groupId": "OG002",
"spread": "930.867",
"value": "1084.2"
},
{
"groupId": "OG003",
"spread": "324.282",
"value": "1168.2"
},
{
"groupId": "OG004",
"spread": "1031.69",
"value": "1505.5"
},
{
"groupId": "OG005",
"spread": "645.68",
"value": "1412.13"
},
{
"groupId": "OG006",
"spread": "879.38",
"value": "1813.56"
}
]
}
],
"title": "Post-Immune NKp46"
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "5"
},
{
"groupId": "OG001",
"value": "5"
},
{
"groupId": "OG002",
"value": "5"
},
{
"groupId": "OG003",
"value": "5"
},
{
"groupId": "OG004",
"value": "4"
},
{
"groupId": "OG005",
"value": "19"
},
{
"groupId": "OG006",
"value": "14"
}
],
"units": "Participants"
}
],
"description": "Activated-NK-cell profiles will be determined via flow cytometry as the expression levels of different activation markers on NK cells in the subject's blood sample.\nData was collected at multiple timepoints throughout the study.\nValues were averaged for each group.\nFor some participants, NKp46 was not assessable.",
"dispersionType": "Standard Deviation",
"groups": [
{
"description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG000",
"title": "Part 1 - Chemovax Schedule A"
},
{
"description": "<p>Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG001",
"title": "Part 1 - Chemovax Schedule B"
},
{
"description": "<p>Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG002",
"title": "Part 1 - Chemovax Schedule C"
},
{
"description": "<p>Feasibility - Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG003",
"title": "Part 1 - Chemovax Schedule D"
},
{
"description": "<p>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG004",
"title": "Part 1 - Chemovax Schedule E"
},
{
"description": "<p>Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG005",
"title": "Part 2 - Chemovax Schedule C"
},
{
"description": "<p>Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25)..</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "OG006",
"title": "Part 3 - Chemovax Schedule C"
}
],
"paramType": "MEAN",
"reportingStatus": "POSTED",
"timeFrame": "Week 1 through Week 70",
"title": "Activation Profiles of NK Cells: Pre-Immune and Post-Immune NKp46",
"type": "SECONDARY",
"unitOfMeasure": "Median Fluorescence Intensity (MFI)"
}
]
},
"participantFlowModule": {
"groups": [
{
"description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "FG000",
"title": "Part 1 - Chemovax Schedule A"
},
{
"description": "<p>Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "FG001",
"title": "Part 1 - Chemovax Schedule B"
},
{
"description": "<p>Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "FG002",
"title": "Part 1 - Chemovax Schedule C"
},
{
"description": "<p>Feasibility - Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "FG003",
"title": "Part 1 - Chemovax Schedule D"
},
{
"description": "<p>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "FG004",
"title": "Part 1 - Chemovax Schedule E"
},
{
"description": "<p>Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "FG005",
"title": "Part 2 - Chemovax Schedule C"
},
{
"description": "<p>Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE/MONTANIDE™ ISA 51 VG vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25</p><p>Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel): Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.</p>",
"id": "FG006",
"title": "Part 3 - Chemovax Schedule C"
}
],
"periods": [
{
"dropWithdraws": [
{
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
},
{
"groupId": "FG001",
"numSubjects": "0"
},
{
"groupId": "FG002",
"numSubjects": "0"
},
{
"groupId": "FG003",
"numSubjects": "0"
},
{
"groupId": "FG004",
"numSubjects": "0"
},
{
"groupId": "FG005",
"numSubjects": "0"
},
{
"groupId": "FG006",
"numSubjects": "0"
}
],
"type": "Adverse Event"
},
{
"reasons": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "0"
},
{
"groupId": "FG002",
"numSubjects": "1"
},
{
"groupId": "FG003",
"numSubjects": "1"
},
{
"groupId": "FG004",
"numSubjects": "0"
},
{
"groupId": "FG005",
"numSubjects": "0"
},
{
"groupId": "FG006",
"numSubjects": "1"
}
],
"type": "Lost to Follow-up"
},
{
"reasons": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "0"
},
{
"groupId": "FG002",
"numSubjects": "0"
},
{
"groupId": "FG003",
"numSubjects": "1"
},
{
"groupId": "FG004",
"numSubjects": "3"
},
{
"groupId": "FG005",
"numSubjects": "0"
},
{
"groupId": "FG006",
"numSubjects": "1"
}
],
"type": "Physician Decision"
},
{
"reasons": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "0"
},
{
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"numSubjects": "1"
},
{
"groupId": "FG003",
"numSubjects": "0"
},
{
"groupId": "FG004",
"numSubjects": "1"
},
{
"groupId": "FG005",
"numSubjects": "1"
},
{
"groupId": "FG006",
"numSubjects": "1"
}
],
"type": "Withdrawal by Subject"
},
{
"reasons": [
{
"groupId": "FG000",
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},
{
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},
{
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},
{
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{
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{
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},
{
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],
"type": "Death"
}
],
"milestones": [
{
"achievements": [
{
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},
{
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{
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{
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{
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},
{
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},
{
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}
],
"type": "STARTED"
},
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "4"
},
{
"groupId": "FG001",
"numSubjects": "5"
},
{
"groupId": "FG002",
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},
{
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{
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{
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},
{
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}
],
"type": "COMPLETED"
},
{
"achievements": [
{
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{
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{
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{
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{
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{
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],
"type": "NOT COMPLETED"
}
],
"title": "Overall Study"
}
],
"recruitmentDetails": "Potential subjects were recruited from the Winthrop P Rockefeller Cancer Institute on the University of Arkansas for Medical Sciences campus and clinics at Highlands Oncology Group."
}
}
}
],
"provenance": {
"from_snapshot_hash": "1b64c904992ddd277d9a9c8ee529682af15960e22230881ab71f824b456b2cc7",
"materiality_event_hash": "c09fe50a7cdcf8348c4f508a03410de07c40ee48cadd23c2fc6286da3177f792",
"patch_hash": "789cb904ff1f6324a6e8dc03fb7fa44b6ff9c645a79f0ab817bb68c4caf1daa1",
"patch_raw_hash": "d9ed9a6319f54d37f519ffe46316ae2664a5e91b36b499b833b154164300d80c",
"patch_source": "ctgov_internal_history",
"patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT02229084/history/16?patchToVersion=17",
"to_snapshot_hash": "70909a794eab1a8f5e457b43ba03450ec7bbc39229c1fc454e7e3c3b2a4f1028"
},
"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/NCT02229084",
"nct_id": "NCT02229084"
},
"versions": {
"from_version": 16,
"submitted_date": "2024-04-26",
"to_version": 17
}
}