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NCT02229084

Vaccination of High Risk Breast Cancer Patients

Version 16 to 17 · University of Arkansas

Patch inspector

Version 16 to 17

53 operations 4 path groups ctgov_internal_history
ClinicalTrials.gov
Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip the pipeline's suppression passes); the authoritative classification is the stored event record.
Plain-language summary

Manual review pending.

Rules fired
arms_or_interventions_changeenrollment_count_change
Value signals
[
  {
    "paths": [
      "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
      "/protocolSection/outcomesModule/primaryOutcomes/1/description",
      "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
      "/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame"
    ],
    "signal": "results_reconciliation_outcome_suppression",
    "category": "results_reconciliation",
    "severity": "low"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:59:17+00
Raw hash
d9ed9a6319f54d37f519ffe46316ae2664a5e91b36b499b833b154164300d80c
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 4 ops
replace /protocolSection/outcomesModule/primaryOutcomes/0/measure
Triage: Critical
Primary Outcome Change Operation 43
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Identify a feasible schedule of vaccination relative to SoC neoadjuvant chemotherapy when the Chemovax are administered concurrently.
After
Identify a Feasible Schedule of Vaccination Relative to SoC Neoadjuvant Chemotherapy When the Chemovax Are Administered Concurrently.
replace /protocolSection/outcomesModule/primaryOutcomes/1/measure
Triage: Critical
Primary Outcome Change Operation 44
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Demonstration of clinical response
After
Determine the pCR Rate
replace /protocolSection/outcomesModule/primaryOutcomes/1/description
Triage: Critical
Primary Outcome Change Operation 45
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Determine if the Chemovax regimen in ER-positive breast cancer would lead to a significantly higher rate of pCR in breast and axillary lymph nodes at time of definitive surgery compared to the corresponding rate reported by von Minckwitz et al.
After
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.
The patient is assessed at the time of surgery for whether they achieved pCR=yes.
They have to do the surgery in order to obtain the tissue samples on which they do their pCR assessment.
replace /protocolSection/outcomesModule/primaryOutcomes/1/timeFrame
Triage: Critical
Primary Outcome Change Operation 46
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Week 73 (±4 weeks) per subject
After
At the time of definitive surgery (4-8 weeks after chemo, which is between Week 22 and Week 25)
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 35 ops
replace /protocolSection/designModule/enrollmentInfo/count
Triage: High
Enrollment Change Operation 8
Matched rules
  • enrollment_count_change Enrollment count changes can signal scope or feasibility shifts.
Before
50
After
58
replace /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
Triage: High
Arm Intervention Change Operation 9
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Biological: Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)
After
Biological: P10s-PADRE/ MONTANIDE™ ISA 51 VG
add /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1
Triage: High
Arm Intervention Change Operation 10
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Doxorubicin
add /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2
Triage: High
Arm Intervention Change Operation 11
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Cyclophosphamide
add /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/3
Triage: High
Arm Intervention Change Operation 12
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Docetaxel
replace /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0
Triage: High
Arm Intervention Change Operation 13
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Biological: Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)
After
Biological: P10s-PADRE/ MONTANIDE™ ISA 51 VG
add /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/1
Triage: High
Arm Intervention Change Operation 14
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Doxorubicin
add /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/2
Triage: High
Arm Intervention Change Operation 15
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Cyclophosphamide
add /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/3
Triage: High
Arm Intervention Change Operation 16
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Docetaxel
replace /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0
Triage: High
Arm Intervention Change Operation 17
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Biological: Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)
After
Biological: P10s-PADRE/ MONTANIDE™ ISA 51 VG
add /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/1
Triage: High
Arm Intervention Change Operation 18
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Doxorubicin
add /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/2
Triage: High
Arm Intervention Change Operation 19
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Cyclophosphamide
add /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/3
Triage: High
Arm Intervention Change Operation 20
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Docetaxel
replace /protocolSection/armsInterventionsModule/armGroups/3/interventionNames/0
Triage: High
Arm Intervention Change Operation 21
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Biological: Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)
After
Biological: P10s-PADRE/ MONTANIDE™ ISA 51 VG
add /protocolSection/armsInterventionsModule/armGroups/3/interventionNames/1
Triage: High
Arm Intervention Change Operation 22
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Doxorubicin
add /protocolSection/armsInterventionsModule/armGroups/3/interventionNames/2
Triage: High
Arm Intervention Change Operation 23
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Cyclophosphamide
add /protocolSection/armsInterventionsModule/armGroups/3/interventionNames/3
Triage: High
Arm Intervention Change Operation 24
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Docetaxel
replace /protocolSection/armsInterventionsModule/armGroups/4/interventionNames/0
Triage: High
Arm Intervention Change Operation 25
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Biological: Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)
After
Biological: P10s-PADRE/ MONTANIDE™ ISA 51 VG
add /protocolSection/armsInterventionsModule/armGroups/4/interventionNames/1
Triage: High
Arm Intervention Change Operation 26
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Doxorubicin
add /protocolSection/armsInterventionsModule/armGroups/4/interventionNames/2
Triage: High
Arm Intervention Change Operation 27
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Cyclophosphamide
add /protocolSection/armsInterventionsModule/armGroups/4/interventionNames/3
Triage: High
Arm Intervention Change Operation 28
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Docetaxel
replace /protocolSection/armsInterventionsModule/armGroups/5/interventionNames/0
Triage: High
Arm Intervention Change Operation 29
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Biological: Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)
After
Biological: P10s-PADRE/ MONTANIDE™ ISA 51 VG
add /protocolSection/armsInterventionsModule/armGroups/5/interventionNames/1
Triage: High
Arm Intervention Change Operation 30
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Doxorubicin
add /protocolSection/armsInterventionsModule/armGroups/5/interventionNames/2
Triage: High
Arm Intervention Change Operation 31
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Cyclophosphamide
add /protocolSection/armsInterventionsModule/armGroups/5/interventionNames/3
Triage: High
Arm Intervention Change Operation 32
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Docetaxel
replace /protocolSection/armsInterventionsModule/armGroups/6/interventionNames/0
Triage: High
Arm Intervention Change Operation 33
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Biological: Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)
After
Biological: P10s-PADRE/ MONTANIDE™ ISA 51 VG
add /protocolSection/armsInterventionsModule/armGroups/6/interventionNames/1
Triage: High
Arm Intervention Change Operation 34
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Doxorubicin
add /protocolSection/armsInterventionsModule/armGroups/6/interventionNames/2
Triage: High
Arm Intervention Change Operation 35
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Cyclophosphamide
add /protocolSection/armsInterventionsModule/armGroups/6/interventionNames/3
Triage: High
Arm Intervention Change Operation 36
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Docetaxel
replace /protocolSection/armsInterventionsModule/interventions/0/name
Triage: High
Arm Intervention Change Operation 37
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)
After
P10s-PADRE/ MONTANIDE™ ISA 51 VG
replace /protocolSection/armsInterventionsModule/interventions/0/description
Triage: High
Arm Intervention Change Operation 38
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
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.
After
Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions concurrent with chemotherapy.
remove /protocolSection/armsInterventionsModule/interventions/0/otherNames
Triage: High
Arm Intervention Change Operation 39
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
[
  "P10s-PADRE/ MONTANIDE™ ISA 51 VG with standard neoadjuvant chemotherapy"
]
add /protocolSection/armsInterventionsModule/interventions/1
Triage: High
Arm Intervention Change Operation 40
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
{
  "name": "Doxorubicin",
  "type": "DRUG",
  "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.",
  "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"
  ]
}
add /protocolSection/armsInterventionsModule/interventions/2
Triage: High
Arm Intervention Change Operation 41
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
{
  "name": "Cyclophosphamide",
  "type": "DRUG",
  "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.",
  "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"
  ]
}
add /protocolSection/armsInterventionsModule/interventions/3
Triage: High
Arm Intervention Change Operation 42
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
{
  "name": "Docetaxel",
  "type": "DRUG",
  "description": "<p>Doxorubicin (60 mg&#x2F;m2) and cyclophosphamide (600 mg&#x2F;m2) (AC) will be administered concurrently every three weeks for four cycles followed by docetaxel (75 mg&#x2F;m2) every three weeks for four cycles.</p><p>If docetaxel is not tolerated, paclitaxel (175mg&#x2F;m2) may be used in its place.</p>",
  "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"
  ]
}
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 1 ops
add /protocolSection/outcomesModule/secondaryOutcomes
Triage: High
Secondary Outcome Change Operation 47
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
[
  {
    "measure": "P10s-MAP-Reactive Immunoglobulin Titers",
    "timeFrame": "Week 1 through Week 70",
    "description": "The anti-P10s binding level was measured via ELISA method after incubation with a subject&#x27;s serum or plasma sample.\nData was collected at multiple timepoints throughout the study.\nValues were averaged for each group."
  },
  {
    "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&#x27;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 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&#x27;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 NKp46",
    "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&#x27;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."
  }
]
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 13 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2023-12
After
2024-04
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2023-12-19
After
2024-04-26
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 3
Before
2023-12-20
After
2024-05-23
add /protocolSection/statusModule/resultsFirstSubmitDate
Triage: Uncategorized
Uncategorized Operation 4
After
2023-12-20
add /protocolSection/statusModule/resultsFirstSubmitQcDate
Triage: Uncategorized
Uncategorized Operation 5
After
2024-04-26
add /protocolSection/statusModule/resultsFirstPostDateStruct
Triage: Uncategorized
Uncategorized Operation 6
After
{
  "date": "2024-05-23",
  "type": "ACTUAL"
}
replace /protocolSection/descriptionModule/detailedDescription
Triage: Uncategorized
Uncategorized Operation 7
Before
<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&#x2F;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.
P10s-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>
After
<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&#x2F;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.
P10s-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&#x2F;II feasibility-and-efficacy study will have three parts.
Its 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.
The study&#x27;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.
To this end, we have defined five different Chemovax schedules, and named them A, B, C, D, and E;</p>
remove /annotationSection
Triage: Uncategorized
Uncategorized Operation 48
Before
{
  "annotationModule": {
    "unpostedAnnotation": {
      "unpostedEvents": [
        {
          "date": "2023-12-20",
          "type": "RELEASE"
        },
        {
          "date": "2024-01-16",
          "type": "RESET"
        },
        {
          "date": "2024-02-07",
          "type": "RELEASE"
        },
        {
          "date": "2024-03-06",
          "type": "RESET"
        },
        {
          "date": "2024-04-01",
          "type": "RELEASE"
        },
        {
          "date": "2024-04-24",
          "type": "RESET"
        }
      ],
      "unpostedResponsibleParty": "University of Arkansas"
    }
  }
}
replace /documentSection/largeDocumentModule/largeDocs/1/uploadDate
Triage: Uncategorized
Uncategorized Operation 49
Before
2023-12-18T11:35
After
2023-12-20T14:08
replace /documentSection/largeDocumentModule/largeDocs/1/filename
Triage: Uncategorized
Uncategorized Operation 50
Before
ICF_001.pdf
After
ICF_002.pdf
replace /documentSection/largeDocumentModule/largeDocs/1/size
Triage: Uncategorized
Uncategorized Operation 51
Before
390179
After
425384
replace /hasResults
Triage: Uncategorized
Uncategorized Operation 52
Before
false
After
true
add /resultsSection
Triage: Uncategorized
Uncategorized Operation 53
After
{
  "moreInfoModule": {
    "pointOfContact": {
      "email": "SBLo@uams.edu",
      "phone": "5016868274",
      "title": "Sorena Lo",
      "organization": "University of Arkansas for Medical Sciences"
    },
    "certainAgreement": {
      "piSponsorEmployee": true
    }
  },
  "adverseEventsModule": {
    "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.",
    "eventGroups": [
      {
        "id": "EG000",
        "title": "Part 1 - Chemovax Schedule A",
        "description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE&#x2F;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&#x2F; 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>",
        "otherNumAtRisk": 5,
        "deathsNumAtRisk": 5,
        "otherNumAffected": 5,
        "seriousNumAtRisk": 5,
        "deathsNumAffected": 0,
        "seriousNumAffected": 4
      },
      {
        "id": "EG001",
        "title": "Part 1 - Chemovax Schedule B",
        "description": "<p>Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE&#x2F;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&#x2F; 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>",
        "otherNumAtRisk": 5,
        "deathsNumAtRisk": 5,
        "otherNumAffected": 5,
        "seriousNumAtRisk": 5,
        "deathsNumAffected": 0,
        "seriousNumAffected": 4
      },
      {
        "id": "EG002",
        "title": "Part 1 - Chemovax Schedule C",
        "description": "<p>Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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>",
        "otherNumAtRisk": 5,
        "deathsNumAtRisk": 5,
        "otherNumAffected": 5,
        "seriousNumAtRisk": 5,
        "deathsNumAffected": 0,
        "seriousNumAffected": 3
      },
      {
        "id": "EG003",
        "title": "Part 1 - Chemovax Schedule D",
        "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&#x2F;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&#x2F; 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>",
        "otherNumAtRisk": 5,
        "deathsNumAtRisk": 5,
        "otherNumAffected": 5,
        "seriousNumAtRisk": 5,
        "deathsNumAffected": 0,
        "seriousNumAffected": 1
      },
      {
        "id": "EG004",
        "title": "Part 1 - Chemovax Schedule E",
        "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&#x2F;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&#x2F; 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>",
        "otherNumAtRisk": 5,
        "deathsNumAtRisk": 5,
        "otherNumAffected": 5,
        "seriousNumAtRisk": 5,
        "deathsNumAffected": 0,
        "seriousNumAffected": 3
      },
      {
        "id": "EG005",
        "title": "Part 2 &amp; 3 Combined - Chemovax Schedule C",
        "description": "<p>Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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>",
        "otherNumAtRisk": 33,
        "deathsNumAtRisk": 33,
        "otherNumAffected": 33,
        "seriousNumAtRisk": 33,
        "deathsNumAffected": 1,
        "seriousNumAffected": 19
      }
    ],
    "otherEvents": [
      {
        "term": "Anemia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 4,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 27,
            "numAffected": 5
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 11,
            "numAffected": 5
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 10,
            "numAffected": 3
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 2,
            "numAffected": 1
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 144,
            "numAffected": 29
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Blood and lymphatic system disorders - Other, specify",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 4,
            "numAffected": 4
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Atrial fibrillation",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 2,
            "numAffected": 1
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 2,
            "numAffected": 1
          }
        ],
        "organSystem": "Cardiac disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Sinus tachycardia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 3,
            "numAffected": 3
          }
        ],
        "organSystem": "Cardiac disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Ear and labyrinth disorders - Other, specify",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 2,
            "numAffected": 1
          }
        ],
        "organSystem": "Ear and labyrinth disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Ear pain",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 2,
            "numAffected": 2
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 4,
            "numAffected": 4
          }
        ],
        "organSystem": "Ear and labyrinth disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Vertigo",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 2,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 3,
            "numAffected": 1
          }
        ],
        "organSystem": "Ear and labyrinth disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Hypothyroidism",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 6,
            "numAffected": 5
          }
        ],
        "organSystem": "Endocrine disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Blurred vision",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 7,
            "numAffected": 6
          }
        ],
        "organSystem": "Eye disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Dry Eye",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 5,
            "numAffected": 3
          }
        ],
        "organSystem": "Eye disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Eye Pain",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Eye disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Watering eyes",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 2,
            "numAffected": 2
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 2,
            "numAffected": 2
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 13,
            "numAffected": 12
          }
        ],
        "organSystem": "Eye disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Abdominal distension",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 2,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Abdominal pain",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 17,
            "numAffected": 11
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Constipation",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 4,
            "numAffected": 2
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 2,
            "numAffected": 2
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 6,
            "numAffected": 4
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 2,
            "numAffected": 2
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 34,
            "numAffected": 22
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Diarrhea",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 3,
            "numAffected": 3
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 3,
            "numAffected": 3
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 3,
            "numAffected": 3
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 30,
            "numAffected": 20
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Dry mouth",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 2,
            "numAffected": 2
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Dyspepsia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 2,
            "numAffected": 1
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 2,
            "numAffected": 2
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 2,
            "numAffected": 2
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Dysphagia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Esophagitis",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Flatulence",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 2,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Gastroesophageal reflux disease",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 1,
            "numAffected": 1
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 16,
            "numAffected": 13
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Gastrointestinal disorders - Other, specify",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 2,
            "numAffected": 2
          },
          {
            "groupId": "EG001",
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        "term": "Edema limbs",
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        "assessmentType": "SYSTEMATIC_ASSESSMENT"
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        "term": "Hypertension",
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        "term": "Thromboembolic event",
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        "term": "Abdominal pain",
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      {
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        ],
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      {
        "term": "Flu like symptoms",
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      {
        "term": "Gait disturbance",
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        "term": "Breast infection",
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          {
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          {
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          {
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          {
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      },
      {
        "term": "Urinary tract obstruction",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Renal and urinary disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Renal and urinary disorders - Other, specify",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Renal and urinary disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Dyspareunia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Reproductive system and breast disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Atelectasis",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Pleural effusion",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 2,
            "numAffected": 2
          }
        ],
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Pulmonary edema",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Rash maculo-papular",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Skin and subcutaneous tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Surgical and medical procedures - Other, specify",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 4,
            "numAffected": 1
          }
        ],
        "organSystem": "Surgical and medical procedures",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Hypotension",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Vascular disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "Vascular disorders - Other, specify",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG002",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG003",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG004",
            "numAtRisk": 5,
            "numEvents": 0,
            "numAffected": 0
          },
          {
            "groupId": "EG005",
            "numAtRisk": 33,
            "numEvents": 1,
            "numAffected": 1
          }
        ],
        "organSystem": "Vascular disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      }
    ],
    "frequencyThreshold": "0"
  },
  "outcomeMeasuresModule": {
    "outcomeMeasures": [
      {
        "type": "PRIMARY",
        "title": "Identify a Feasible Schedule of Vaccination Relative to SoC Neoadjuvant Chemotherapy When the Chemovax Are Administered Concurrently.",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "5",
                "groupId": "OG000"
              },
              {
                "value": "5",
                "groupId": "OG001"
              },
              {
                "value": "5",
                "groupId": "OG002"
              },
              {
                "value": "5",
                "groupId": "OG003"
              },
              {
                "value": "5",
                "groupId": "OG004"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Part 1 - Chemovax Schedule A",
            "description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE&#x2F;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&#x2F; 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 B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE&#x2F;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&#x2F; 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 C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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 D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "title": "Greater than or equal to 4-fold increase",
                "measurements": [
                  {
                    "value": "3",
                    "groupId": "OG000"
                  },
                  {
                    "value": "2",
                    "groupId": "OG001"
                  },
                  {
                    "value": "4",
                    "groupId": "OG002"
                  },
                  {
                    "value": "2",
                    "groupId": "OG003"
                  },
                  {
                    "value": "4",
                    "groupId": "OG004"
                  }
                ]
              },
              {
                "title": "Less than 4-fold increase",
                "measurements": [
                  {
                    "value": "2",
                    "groupId": "OG000"
                  },
                  {
                    "value": "3",
                    "groupId": "OG001"
                  },
                  {
                    "value": "1",
                    "groupId": "OG002"
                  },
                  {
                    "value": "3",
                    "groupId": "OG003"
                  },
                  {
                    "value": "1",
                    "groupId": "OG004"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "timeFrame": "At the time of definitive surgery (4-8 weeks after chemo, which is between Week 22 and Week 25)",
        "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>",
        "unitOfMeasure": "Participants",
        "reportingStatus": "POSTED",
        "populationDescription": "This was defined as a &gt;4-fold increase in a subject&#x27;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."
      },
      {
        "type": "PRIMARY",
        "title": "Determine the pCR Rate",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "0",
                "groupId": "OG000"
              },
              {
                "value": "0",
                "groupId": "OG001"
              },
              {
                "value": "0",
                "groupId": "OG002"
              },
              {
                "value": "0",
                "groupId": "OG003"
              },
              {
                "value": "0",
                "groupId": "OG004"
              },
              {
                "value": "19",
                "groupId": "OG005"
              },
              {
                "value": "14",
                "groupId": "OG006"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Part 1 - Chemovax Schedule A",
            "description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE&#x2F;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&#x2F; 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 B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE&#x2F;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&#x2F; 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 C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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 D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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",
            "description": "<p>Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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>"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "OG000"
                  },
                  {
                    "value": "0",
                    "groupId": "OG001"
                  },
                  {
                    "value": "0",
                    "groupId": "OG002"
                  },
                  {
                    "value": "0",
                    "groupId": "OG003"
                  },
                  {
                    "value": "0",
                    "groupId": "OG004"
                  },
                  {
                    "value": "3",
                    "groupId": "OG005"
                  },
                  {
                    "value": "1",
                    "groupId": "OG006"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "timeFrame": "At the time of definitive surgery (4-8 weeks after chemo, which is between Week 22 and Week 25)",
        "description": "The patient-level primary outcome for this objective is pCR, which is binary yes&#x2F;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.",
        "unitOfMeasure": "Participants",
        "reportingStatus": "POSTED",
        "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&#x27;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."
      },
      {
        "type": "SECONDARY",
        "title": "P10s-MAP-Reactive Immunoglobulin Titers",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "5",
                "groupId": "OG000"
              },
              {
                "value": "5",
                "groupId": "OG001"
              },
              {
                "value": "5",
                "groupId": "OG002"
              },
              {
                "value": "5",
                "groupId": "OG003"
              },
              {
                "value": "5",
                "groupId": "OG004"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Part 1 - Chemovax Schedule A",
            "description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE&#x2F;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&#x2F; 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 B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE&#x2F;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&#x2F; 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 C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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 D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "10.72",
                    "spread": "14.97",
                    "groupId": "OG000"
                  },
                  {
                    "value": "9.76",
                    "spread": "13.91",
                    "groupId": "OG001"
                  },
                  {
                    "value": "42.25",
                    "spread": "71.94",
                    "groupId": "OG002"
                  },
                  {
                    "value": "4.38",
                    "spread": "5.10",
                    "groupId": "OG003"
                  },
                  {
                    "value": "6.74",
                    "spread": "7",
                    "groupId": "OG004"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEAN",
        "timeFrame": "Week 1 through Week 70",
        "description": "The anti-P10s binding level was measured via ELISA method after incubation with a subject&#x27;s serum or plasma sample.\nData was collected at multiple timepoints throughout the study.\nValues were averaged for each group.",
        "unitOfMeasure": "titers",
        "dispersionType": "Standard Deviation",
        "reportingStatus": "POSTED"
      },
      {
        "type": "SECONDARY",
        "title": "Activation Profiles of NK Cells: Pre-Immune and Post-Immune CD16",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "5",
                "groupId": "OG000"
              },
              {
                "value": "5",
                "groupId": "OG001"
              },
              {
                "value": "5",
                "groupId": "OG002"
              },
              {
                "value": "5",
                "groupId": "OG003"
              },
              {
                "value": "4",
                "groupId": "OG004"
              },
              {
                "value": "19",
                "groupId": "OG005"
              },
              {
                "value": "14",
                "groupId": "OG006"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Part 1 - Chemovax Schedule A",
            "description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE&#x2F;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&#x2F; 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 B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE&#x2F;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&#x2F; 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 C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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 D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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",
            "description": "<p>Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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>"
          }
        ],
        "classes": [
          {
            "title": "Pre-Immune CD16",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "26065",
                    "spread": "7976.46",
                    "groupId": "OG000"
                  },
                  {
                    "value": "26580",
                    "spread": "2261.51",
                    "groupId": "OG001"
                  },
                  {
                    "value": "25171.8",
                    "spread": "6493",
                    "groupId": "OG002"
                  },
                  {
                    "value": "28546",
                    "spread": "7197.16",
                    "groupId": "OG003"
                  },
                  {
                    "value": "24897",
                    "spread": "5334.72",
                    "groupId": "OG004"
                  },
                  {
                    "value": "67445.83",
                    "spread": "31389.28",
                    "groupId": "OG005"
                  },
                  {
                    "value": "68619.59",
                    "spread": "27944.66",
                    "groupId": "OG006"
                  }
                ]
              }
            ]
          },
          {
            "title": "Post-Immune CD16",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "19745.4",
                    "spread": "5182.72",
                    "groupId": "OG000"
                  },
                  {
                    "value": "20993.4",
                    "spread": "7061.48",
                    "groupId": "OG001"
                  },
                  {
                    "value": "27998.6",
                    "spread": "10142.41",
                    "groupId": "OG002"
                  },
                  {
                    "value": "22959.8",
                    "spread": "6020.06",
                    "groupId": "OG003"
                  },
                  {
                    "value": "25711.75",
                    "spread": "20572.69",
                    "groupId": "OG004"
                  },
                  {
                    "value": "62323.05",
                    "spread": "24021.75",
                    "groupId": "OG005"
                  },
                  {
                    "value": "65410.12",
                    "spread": "24645.52",
                    "groupId": "OG006"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEAN",
        "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&#x27;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.",
        "unitOfMeasure": "Median Fluorescence Intensity (MFI)",
        "dispersionType": "Standard Deviation",
        "reportingStatus": "POSTED"
      },
      {
        "type": "SECONDARY",
        "title": "Activation Profiles of NK Cells: Pre-Immune and Post-Immune CD69",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "5",
                "groupId": "OG000"
              },
              {
                "value": "5",
                "groupId": "OG001"
              },
              {
                "value": "5",
                "groupId": "OG002"
              },
              {
                "value": "5",
                "groupId": "OG003"
              },
              {
                "value": "4",
                "groupId": "OG004"
              },
              {
                "value": "19",
                "groupId": "OG005"
              },
              {
                "value": "14",
                "groupId": "OG006"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Part 1 - Chemovax Schedule A",
            "description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE&#x2F;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&#x2F; 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 B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE&#x2F;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&#x2F; 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 C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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 D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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",
            "description": "<p>Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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>"
          }
        ],
        "classes": [
          {
            "title": "Pre-Immune CD69",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "268.2",
                    "spread": "50.08",
                    "groupId": "OG000"
                  },
                  {
                    "value": "300.8",
                    "spread": "88.02",
                    "groupId": "OG001"
                  },
                  {
                    "value": "291.4",
                    "spread": "38.55",
                    "groupId": "OG002"
                  },
                  {
                    "value": "294.6",
                    "spread": "57.27",
                    "groupId": "OG003"
                  },
                  {
                    "value": "296.25",
                    "spread": "34.37",
                    "groupId": "OG004"
                  },
                  {
                    "value": "428",
                    "spread": "133",
                    "groupId": "OG005"
                  },
                  {
                    "value": "445.5",
                    "spread": "169.17",
                    "groupId": "OG006"
                  }
                ]
              }
            ]
          },
          {
            "title": "Post-Immune CD69",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "307",
                    "spread": "72.29",
                    "groupId": "OG000"
                  },
                  {
                    "value": "329.6",
                    "spread": "26.23",
                    "groupId": "OG001"
                  },
                  {
                    "value": "275",
                    "spread": "25.25",
                    "groupId": "OG002"
                  },
                  {
                    "value": "278.4",
                    "spread": "27.87",
                    "groupId": "OG003"
                  },
                  {
                    "value": "311.25",
                    "spread": "16.76",
                    "groupId": "OG004"
                  },
                  {
                    "value": "489.44",
                    "spread": "139.9",
                    "groupId": "OG005"
                  },
                  {
                    "value": "505.97",
                    "spread": "161.11",
                    "groupId": "OG006"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEAN",
        "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&#x27;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.",
        "unitOfMeasure": "Median Fluorescence Intensity (MFI)",
        "dispersionType": "Standard Deviation",
        "reportingStatus": "POSTED"
      },
      {
        "type": "SECONDARY",
        "title": "Activation Profiles of NK Cells: Pre-Immune and Post-Immune NKp46",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "5",
                "groupId": "OG000"
              },
              {
                "value": "5",
                "groupId": "OG001"
              },
              {
                "value": "5",
                "groupId": "OG002"
              },
              {
                "value": "5",
                "groupId": "OG003"
              },
              {
                "value": "4",
                "groupId": "OG004"
              },
              {
                "value": "19",
                "groupId": "OG005"
              },
              {
                "value": "14",
                "groupId": "OG006"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Part 1 - Chemovax Schedule A",
            "description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE&#x2F;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&#x2F; 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 B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE&#x2F;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&#x2F; 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 C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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 D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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",
            "description": "<p>Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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>"
          }
        ],
        "classes": [
          {
            "title": "Pre-Immune NKp46",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "685.2",
                    "spread": "390.469",
                    "groupId": "OG000"
                  },
                  {
                    "value": "590.4",
                    "spread": "204.147",
                    "groupId": "OG001"
                  },
                  {
                    "value": "724.2",
                    "spread": "422.436",
                    "groupId": "OG002"
                  },
                  {
                    "value": "794.2",
                    "spread": "355.618",
                    "groupId": "OG003"
                  },
                  {
                    "value": "744.25",
                    "spread": "251.998",
                    "groupId": "OG004"
                  },
                  {
                    "value": "1360.33",
                    "spread": "638.97",
                    "groupId": "OG005"
                  },
                  {
                    "value": "1650.08",
                    "spread": "878.64",
                    "groupId": "OG006"
                  }
                ]
              }
            ]
          },
          {
            "title": "Post-Immune NKp46",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "1391",
                    "spread": "489.819",
                    "groupId": "OG000"
                  },
                  {
                    "value": "1115.6",
                    "spread": "485.348",
                    "groupId": "OG001"
                  },
                  {
                    "value": "1084.2",
                    "spread": "930.867",
                    "groupId": "OG002"
                  },
                  {
                    "value": "1168.2",
                    "spread": "324.282",
                    "groupId": "OG003"
                  },
                  {
                    "value": "1505.5",
                    "spread": "1031.69",
                    "groupId": "OG004"
                  },
                  {
                    "value": "1412.13",
                    "spread": "645.68",
                    "groupId": "OG005"
                  },
                  {
                    "value": "1813.56",
                    "spread": "879.38",
                    "groupId": "OG006"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEAN",
        "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&#x27;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.",
        "unitOfMeasure": "Median Fluorescence Intensity (MFI)",
        "dispersionType": "Standard Deviation",
        "reportingStatus": "POSTED"
      }
    ]
  },
  "participantFlowModule": {
    "groups": [
      {
        "id": "FG000",
        "title": "Part 1 - Chemovax Schedule A",
        "description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE&#x2F;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&#x2F; 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 B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE&#x2F;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&#x2F; 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 C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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 D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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",
        "description": "<p>Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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>"
      }
    ],
    "periods": [
      {
        "title": "Overall Study",
        "milestones": [
          {
            "type": "STARTED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "5"
              },
              {
                "groupId": "FG001",
                "numSubjects": "5"
              },
              {
                "groupId": "FG002",
                "numSubjects": "5"
              },
              {
                "groupId": "FG003",
                "numSubjects": "5"
              },
              {
                "groupId": "FG004",
                "numSubjects": "5"
              },
              {
                "groupId": "FG005",
                "numSubjects": "19"
              },
              {
                "groupId": "FG006",
                "numSubjects": "14"
              }
            ]
          },
          {
            "type": "COMPLETED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "4"
              },
              {
                "groupId": "FG001",
                "numSubjects": "5"
              },
              {
                "groupId": "FG002",
                "numSubjects": "3"
              },
              {
                "groupId": "FG003",
                "numSubjects": "3"
              },
              {
                "groupId": "FG004",
                "numSubjects": "1"
              },
              {
                "groupId": "FG005",
                "numSubjects": "18"
              },
              {
                "groupId": "FG006",
                "numSubjects": "10"
              }
            ]
          },
          {
            "type": "NOT COMPLETED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "1"
              },
              {
                "groupId": "FG001",
                "numSubjects": "0"
              },
              {
                "groupId": "FG002",
                "numSubjects": "2"
              },
              {
                "groupId": "FG003",
                "numSubjects": "2"
              },
              {
                "groupId": "FG004",
                "numSubjects": "4"
              },
              {
                "groupId": "FG005",
                "numSubjects": "1"
              },
              {
                "groupId": "FG006",
                "numSubjects": "4"
              }
            ]
          }
        ],
        "dropWithdraws": [
          {
            "type": "Adverse Event",
            "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": "Lost to Follow-up",
            "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": "Physician Decision",
            "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": "Withdrawal by Subject",
            "reasons": [
              {
                "groupId": "FG000",
                "numSubjects": "0"
              },
              {
                "groupId": "FG001",
                "numSubjects": "0"
              },
              {
                "groupId": "FG002",
                "numSubjects": "1"
              },
              {
                "groupId": "FG003",
                "numSubjects": "0"
              },
              {
                "groupId": "FG004",
                "numSubjects": "1"
              },
              {
                "groupId": "FG005",
                "numSubjects": "1"
              },
              {
                "groupId": "FG006",
                "numSubjects": "1"
              }
            ]
          },
          {
            "type": "Death",
            "reasons": [
              {
                "groupId": "FG000",
                "numSubjects": "0"
              },
              {
                "groupId": "FG001",
                "numSubjects": "0"
              },
              {
                "groupId": "FG002",
                "numSubjects": "0"
              },
              {
                "groupId": "FG003",
                "numSubjects": "0"
              },
              {
                "groupId": "FG004",
                "numSubjects": "0"
              },
              {
                "groupId": "FG005",
                "numSubjects": "0"
              },
              {
                "groupId": "FG006",
                "numSubjects": "1"
              }
            ]
          }
        ]
      }
    ],
    "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."
  },
  "baselineCharacteristicsModule": {
    "denoms": [
      {
        "units": "Participants",
        "counts": [
          {
            "value": "5",
            "groupId": "BG000"
          },
          {
            "value": "5",
            "groupId": "BG001"
          },
          {
            "value": "5",
            "groupId": "BG002"
          },
          {
            "value": "5",
            "groupId": "BG003"
          },
          {
            "value": "5",
            "groupId": "BG004"
          },
          {
            "value": "19",
            "groupId": "BG005"
          },
          {
            "value": "14",
            "groupId": "BG006"
          },
          {
            "value": "58",
            "groupId": "BG007"
          }
        ]
      }
    ],
    "groups": [
      {
        "id": "BG000",
        "title": "Part 1 - Chemovax Schedule A",
        "description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE&#x2F;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&#x2F; 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 B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE&#x2F;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&#x2F; 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 C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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 D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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": "<p>Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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": "BG007",
        "title": "Total",
        "description": "Total of all reporting groups"
      }
    ],
    "measures": [
      {
        "title": "Age, Categorical",
        "classes": [
          {
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "19",
                    "groupId": "BG005"
                  },
                  {
                    "value": "14",
                    "groupId": "BG006"
                  },
                  {
                    "value": "58",
                    "groupId": "BG007"
                  }
                ]
              }
            ],
            "categories": [
              {
                "title": "&lt;=18 years",
                "measurements": [
                  {
                    "value": "0",
                    "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"
                  }
                ]
              },
              {
                "title": "Between 18 and 65 years",
                "measurements": [
                  {
                    "value": "4",
                    "groupId": "BG000"
                  },
                  {
                    "value": "4",
                    "groupId": "BG001"
                  },
                  {
                    "value": "4",
                    "groupId": "BG002"
                  },
                  {
                    "value": "3",
                    "groupId": "BG003"
                  },
                  {
                    "value": "4",
                    "groupId": "BG004"
                  },
                  {
                    "value": "17",
                    "groupId": "BG005"
                  },
                  {
                    "value": "13",
                    "groupId": "BG006"
                  },
                  {
                    "value": "49",
                    "groupId": "BG007"
                  }
                ]
              },
              {
                "title": "&gt;=65 years",
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "BG000"
                  },
                  {
                    "value": "1",
                    "groupId": "BG001"
                  },
                  {
                    "value": "1",
                    "groupId": "BG002"
                  },
                  {
                    "value": "2",
                    "groupId": "BG003"
                  },
                  {
                    "value": "1",
                    "groupId": "BG004"
                  },
                  {
                    "value": "2",
                    "groupId": "BG005"
                  },
                  {
                    "value": "1",
                    "groupId": "BG006"
                  },
                  {
                    "value": "9",
                    "groupId": "BG007"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Age, Continuous",
        "classes": [
          {
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "19",
                    "groupId": "BG005"
                  },
                  {
                    "value": "14",
                    "groupId": "BG006"
                  },
                  {
                    "value": "58",
                    "groupId": "BG007"
                  }
                ]
              }
            ],
            "categories": [
              {
                "measurements": [
                  {
                    "value": "59",
                    "spread": "12.37",
                    "groupId": "BG000"
                  },
                  {
                    "value": "53",
                    "spread": "10.2",
                    "groupId": "BG001"
                  },
                  {
                    "value": "57.6",
                    "spread": "11.69",
                    "groupId": "BG002"
                  },
                  {
                    "value": "54.8",
                    "spread": "15.42",
                    "groupId": "BG003"
                  },
                  {
                    "value": "43.4",
                    "spread": "15.24",
                    "groupId": "BG004"
                  },
                  {
                    "value": "52.58",
                    "spread": "10.73",
                    "groupId": "BG005"
                  },
                  {
                    "value": "46.86",
                    "spread": "10.73",
                    "groupId": "BG006"
                  },
                  {
                    "value": "50.15",
                    "spread": "10.94",
                    "groupId": "BG007"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEAN",
        "unitOfMeasure": "years",
        "dispersionType": "STANDARD_DEVIATION"
      },
      {
        "title": "Sex: Female, Male",
        "classes": [
          {
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "19",
                    "groupId": "BG005"
                  },
                  {
                    "value": "14",
                    "groupId": "BG006"
                  },
                  {
                    "value": "58",
                    "groupId": "BG007"
                  }
                ]
              }
            ],
            "categories": [
              {
                "title": "Female",
                "measurements": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "19",
                    "groupId": "BG005"
                  },
                  {
                    "value": "14",
                    "groupId": "BG006"
                  },
                  {
                    "value": "58",
                    "groupId": "BG007"
                  }
                ]
              },
              {
                "title": "Male",
                "measurements": [
                  {
                    "value": "0",
                    "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"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Ethnicity (NIH&#x2F;OMB)",
        "classes": [
          {
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "19",
                    "groupId": "BG005"
                  },
                  {
                    "value": "14",
                    "groupId": "BG006"
                  },
                  {
                    "value": "58",
                    "groupId": "BG007"
                  }
                ]
              }
            ],
            "categories": [
              {
                "title": "Hispanic or Latino",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  },
                  {
                    "value": "0",
                    "groupId": "BG003"
                  },
                  {
                    "value": "0",
                    "groupId": "BG004"
                  },
                  {
                    "value": "0",
                    "groupId": "BG005"
                  },
                  {
                    "value": "2",
                    "groupId": "BG006"
                  },
                  {
                    "value": "2",
                    "groupId": "BG007"
                  }
                ]
              },
              {
                "title": "Not Hispanic or Latino",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  },
                  {
                    "value": "0",
                    "groupId": "BG003"
                  },
                  {
                    "value": "0",
                    "groupId": "BG004"
                  },
                  {
                    "value": "10",
                    "groupId": "BG005"
                  },
                  {
                    "value": "6",
                    "groupId": "BG006"
                  },
                  {
                    "value": "16",
                    "groupId": "BG007"
                  }
                ]
              },
              {
                "title": "Unknown or Not Reported",
                "measurements": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "9",
                    "groupId": "BG005"
                  },
                  {
                    "value": "6",
                    "groupId": "BG006"
                  },
                  {
                    "value": "40",
                    "groupId": "BG007"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Race&#x2F;Ethnicity, Customized",
        "classes": [
          {
            "title": "American Indian or Alaska Native",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "19",
                    "groupId": "BG005"
                  },
                  {
                    "value": "14",
                    "groupId": "BG006"
                  },
                  {
                    "value": "58",
                    "groupId": "BG007"
                  }
                ]
              }
            ],
            "categories": [
              {
                "measurements": [
                  {
                    "value": "0",
                    "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"
                  }
                ]
              }
            ]
          },
          {
            "title": "Asian",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "19",
                    "groupId": "BG005"
                  },
                  {
                    "value": "14",
                    "groupId": "BG006"
                  },
                  {
                    "value": "58",
                    "groupId": "BG007"
                  }
                ]
              }
            ],
            "categories": [
              {
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "1",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  },
                  {
                    "value": "0",
                    "groupId": "BG003"
                  },
                  {
                    "value": "0",
                    "groupId": "BG004"
                  },
                  {
                    "value": "0",
                    "groupId": "BG005"
                  },
                  {
                    "value": "1",
                    "groupId": "BG006"
                  },
                  {
                    "value": "2",
                    "groupId": "BG007"
                  }
                ]
              }
            ]
          },
          {
            "title": "Native Hawaiian or Pacific Islander",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "19",
                    "groupId": "BG005"
                  },
                  {
                    "value": "14",
                    "groupId": "BG006"
                  },
                  {
                    "value": "58",
                    "groupId": "BG007"
                  }
                ]
              }
            ],
            "categories": [
              {
                "measurements": [
                  {
                    "value": "0",
                    "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"
                  }
                ]
              }
            ]
          },
          {
            "title": "Black or African American",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "19",
                    "groupId": "BG005"
                  },
                  {
                    "value": "14",
                    "groupId": "BG006"
                  },
                  {
                    "value": "58",
                    "groupId": "BG007"
                  }
                ]
              }
            ],
            "categories": [
              {
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "1",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  },
                  {
                    "value": "0",
                    "groupId": "BG003"
                  },
                  {
                    "value": "0",
                    "groupId": "BG004"
                  },
                  {
                    "value": "5",
                    "groupId": "BG005"
                  },
                  {
                    "value": "3",
                    "groupId": "BG006"
                  },
                  {
                    "value": "9",
                    "groupId": "BG007"
                  }
                ]
              }
            ]
          },
          {
            "title": "White",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "19",
                    "groupId": "BG005"
                  },
                  {
                    "value": "14",
                    "groupId": "BG006"
                  },
                  {
                    "value": "58",
                    "groupId": "BG007"
                  }
                ]
              }
            ],
            "categories": [
              {
                "measurements": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "3",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "14",
                    "groupId": "BG005"
                  },
                  {
                    "value": "8",
                    "groupId": "BG006"
                  },
                  {
                    "value": "45",
                    "groupId": "BG007"
                  }
                ]
              }
            ]
          },
          {
            "title": "Other",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "19",
                    "groupId": "BG005"
                  },
                  {
                    "value": "14",
                    "groupId": "BG006"
                  },
                  {
                    "value": "58",
                    "groupId": "BG007"
                  }
                ]
              }
            ],
            "categories": [
              {
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  },
                  {
                    "value": "0",
                    "groupId": "BG003"
                  },
                  {
                    "value": "0",
                    "groupId": "BG004"
                  },
                  {
                    "value": "0",
                    "groupId": "BG005"
                  },
                  {
                    "value": "2",
                    "groupId": "BG006"
                  },
                  {
                    "value": "2",
                    "groupId": "BG007"
                  }
                ]
              }
            ]
          },
          {
            "title": "More than one race",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "19",
                    "groupId": "BG005"
                  },
                  {
                    "value": "14",
                    "groupId": "BG006"
                  },
                  {
                    "value": "58",
                    "groupId": "BG007"
                  }
                ]
              }
            ],
            "categories": [
              {
                "measurements": [
                  {
                    "value": "0",
                    "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"
                  }
                ]
              }
            ]
          },
          {
            "title": "Unknown or Not Reported",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "19",
                    "groupId": "BG005"
                  },
                  {
                    "value": "14",
                    "groupId": "BG006"
                  },
                  {
                    "value": "58",
                    "groupId": "BG007"
                  }
                ]
              }
            ],
            "categories": [
              {
                "measurements": [
                  {
                    "value": "0",
                    "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"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Region of Enrollment",
        "classes": [
          {
            "title": "United States",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "19",
                    "groupId": "BG005"
                  },
                  {
                    "value": "14",
                    "groupId": "BG006"
                  },
                  {
                    "value": "58",
                    "groupId": "BG007"
                  }
                ]
              }
            ],
            "categories": [
              {
                "title": "Central Arkansas at University of Arkansas for Medical Sciences",
                "measurements": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "2",
                    "groupId": "BG002"
                  },
                  {
                    "value": "1",
                    "groupId": "BG003"
                  },
                  {
                    "value": "0",
                    "groupId": "BG004"
                  },
                  {
                    "value": "10",
                    "groupId": "BG005"
                  },
                  {
                    "value": "14",
                    "groupId": "BG006"
                  },
                  {
                    "value": "37",
                    "groupId": "BG007"
                  }
                ]
              },
              {
                "title": "Northwest Arkansas at Highlands Oncology Group",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "3",
                    "groupId": "BG002"
                  },
                  {
                    "value": "4",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "9",
                    "groupId": "BG005"
                  },
                  {
                    "value": "0",
                    "groupId": "BG006"
                  },
                  {
                    "value": "21",
                    "groupId": "BG007"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Eastern Cooperative Oncology Group (ECOG) Performance Status",
        "classes": [
          {
            "title": "0 Fully active, able to carry on all pre-disease",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "19",
                    "groupId": "BG005"
                  },
                  {
                    "value": "14",
                    "groupId": "BG006"
                  },
                  {
                    "value": "58",
                    "groupId": "BG007"
                  }
                ]
              }
            ],
            "categories": [
              {
                "measurements": [
                  {
                    "value": "4",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "4",
                    "groupId": "BG003"
                  },
                  {
                    "value": "4",
                    "groupId": "BG004"
                  },
                  {
                    "value": "18",
                    "groupId": "BG005"
                  },
                  {
                    "value": "13",
                    "groupId": "BG006"
                  },
                  {
                    "value": "53",
                    "groupId": "BG007"
                  }
                ]
              }
            ]
          },
          {
            "title": "1 Restricted in physically strenuous activity but ambulatory and able to carry out work",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "19",
                    "groupId": "BG005"
                  },
                  {
                    "value": "14",
                    "groupId": "BG006"
                  },
                  {
                    "value": "58",
                    "groupId": "BG007"
                  }
                ]
              }
            ],
            "categories": [
              {
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  },
                  {
                    "value": "1",
                    "groupId": "BG003"
                  },
                  {
                    "value": "1",
                    "groupId": "BG004"
                  },
                  {
                    "value": "1",
                    "groupId": "BG005"
                  },
                  {
                    "value": "1",
                    "groupId": "BG006"
                  },
                  {
                    "value": "5",
                    "groupId": "BG007"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "description": "Measure of how cancer affects a person&#x27;s day-to-day life (https:&#x2F;&#x2F;ecog-acrin.org&#x2F;resources&#x2F;ecog-performance-status&#x2F;).\nIn this study, having a score of 0-1 was a criterion for eligibility.",
        "unitOfMeasure": "Participants",
        "populationDescription": "For 1 participant in Part 2, ECOG Performance was not given."
      },
      {
        "title": "Pre-Treatment Tumor Size",
        "classes": [
          {
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "19",
                    "groupId": "BG005"
                  },
                  {
                    "value": "13",
                    "groupId": "BG006"
                  },
                  {
                    "value": "57",
                    "groupId": "BG007"
                  }
                ]
              }
            ],
            "categories": [
              {
                "measurements": [
                  {
                    "value": "2.9",
                    "spread": ".84",
                    "groupId": "BG000"
                  },
                  {
                    "value": "4.06",
                    "spread": "1.44",
                    "groupId": "BG001"
                  },
                  {
                    "value": "4.82",
                    "spread": "2.03",
                    "groupId": "BG002"
                  },
                  {
                    "value": "3.76",
                    "spread": "2.56",
                    "groupId": "BG003"
                  },
                  {
                    "value": "1.96",
                    "spread": "0.82",
                    "groupId": "BG004"
                  },
                  {
                    "value": "4.13",
                    "spread": "2.67",
                    "groupId": "BG005"
                  },
                  {
                    "value": "5.43",
                    "spread": "2.19",
                    "groupId": "BG006"
                  },
                  {
                    "value": "4.03",
                    "spread": "2.38",
                    "groupId": "BG007"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEAN",
        "description": "Length of longest diameter of tumor measured in centimeters.",
        "unitOfMeasure": "centimeters",
        "dispersionType": "STANDARD_DEVIATION",
        "populationDescription": "For 1 participant in Part 3, pre-treatment tumor size was not reported."
      },
      {
        "title": "American Joint Committee on Cancer (AJCC) Tumor Staging",
        "classes": [
          {
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "18",
                    "groupId": "BG005"
                  },
                  {
                    "value": "14",
                    "groupId": "BG006"
                  },
                  {
                    "value": "57",
                    "groupId": "BG007"
                  }
                ]
              }
            ],
            "categories": [
              {
                "title": "Stage IA",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  },
                  {
                    "value": "1",
                    "groupId": "BG003"
                  },
                  {
                    "value": "1",
                    "groupId": "BG004"
                  },
                  {
                    "value": "2",
                    "groupId": "BG005"
                  },
                  {
                    "value": "0",
                    "groupId": "BG006"
                  },
                  {
                    "value": "4",
                    "groupId": "BG007"
                  }
                ]
              },
              {
                "title": "Stage IB",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  },
                  {
                    "value": "0",
                    "groupId": "BG003"
                  },
                  {
                    "value": "0",
                    "groupId": "BG004"
                  },
                  {
                    "value": "0",
                    "groupId": "BG005"
                  },
                  {
                    "value": "1",
                    "groupId": "BG006"
                  },
                  {
                    "value": "1",
                    "groupId": "BG007"
                  }
                ]
              },
              {
                "title": "Stage II",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  },
                  {
                    "value": "1",
                    "groupId": "BG003"
                  },
                  {
                    "value": "0",
                    "groupId": "BG004"
                  },
                  {
                    "value": "1",
                    "groupId": "BG005"
                  },
                  {
                    "value": "3",
                    "groupId": "BG006"
                  },
                  {
                    "value": "5",
                    "groupId": "BG007"
                  }
                ]
              },
              {
                "title": "Stage IIA",
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "BG000"
                  },
                  {
                    "value": "2",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  },
                  {
                    "value": "1",
                    "groupId": "BG003"
                  },
                  {
                    "value": "1",
                    "groupId": "BG004"
                  },
                  {
                    "value": "4",
                    "groupId": "BG005"
                  },
                  {
                    "value": "2",
                    "groupId": "BG006"
                  },
                  {
                    "value": "11",
                    "groupId": "BG007"
                  }
                ]
              },
              {
                "title": "Stage IIB",
                "measurements": [
                  {
                    "value": "3",
                    "groupId": "BG000"
                  },
                  {
                    "value": "1",
                    "groupId": "BG001"
                  },
                  {
                    "value": "2",
                    "groupId": "BG002"
                  },
                  {
                    "value": "1",
                    "groupId": "BG003"
                  },
                  {
                    "value": "2",
                    "groupId": "BG004"
                  },
                  {
                    "value": "4",
                    "groupId": "BG005"
                  },
                  {
                    "value": "4",
                    "groupId": "BG006"
                  },
                  {
                    "value": "17",
                    "groupId": "BG007"
                  }
                ]
              },
              {
                "title": "Stage III",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  },
                  {
                    "value": "1",
                    "groupId": "BG003"
                  },
                  {
                    "value": "0",
                    "groupId": "BG004"
                  },
                  {
                    "value": "3",
                    "groupId": "BG005"
                  },
                  {
                    "value": "2",
                    "groupId": "BG006"
                  },
                  {
                    "value": "6",
                    "groupId": "BG007"
                  }
                ]
              },
              {
                "title": "Stage IIIA",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "1",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  },
                  {
                    "value": "0",
                    "groupId": "BG003"
                  },
                  {
                    "value": "0",
                    "groupId": "BG004"
                  },
                  {
                    "value": "2",
                    "groupId": "BG005"
                  },
                  {
                    "value": "1",
                    "groupId": "BG006"
                  },
                  {
                    "value": "4",
                    "groupId": "BG007"
                  }
                ]
              },
              {
                "title": "Stage IIIB",
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "BG000"
                  },
                  {
                    "value": "1",
                    "groupId": "BG001"
                  },
                  {
                    "value": "2",
                    "groupId": "BG002"
                  },
                  {
                    "value": "0",
                    "groupId": "BG003"
                  },
                  {
                    "value": "1",
                    "groupId": "BG004"
                  },
                  {
                    "value": "2",
                    "groupId": "BG005"
                  },
                  {
                    "value": "1",
                    "groupId": "BG006"
                  },
                  {
                    "value": "8",
                    "groupId": "BG007"
                  }
                ]
              },
              {
                "title": "Stage not reported&#x2F;given",
                "measurements": [
                  {
                    "value": "0",
                    "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"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_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>",
        "unitOfMeasure": "Participants",
        "populationDescription": "For 2 participants, both in Part 2, AJCC stage was not given."
      },
      {
        "title": "Tumor Grade",
        "classes": [
          {
            "title": "Grade I",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "19",
                    "groupId": "BG005"
                  },
                  {
                    "value": "14",
                    "groupId": "BG006"
                  },
                  {
                    "value": "58",
                    "groupId": "BG007"
                  }
                ]
              }
            ],
            "categories": [
              {
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "1",
                    "groupId": "BG002"
                  },
                  {
                    "value": "0",
                    "groupId": "BG003"
                  },
                  {
                    "value": "0",
                    "groupId": "BG004"
                  },
                  {
                    "value": "2",
                    "groupId": "BG005"
                  },
                  {
                    "value": "3",
                    "groupId": "BG006"
                  },
                  {
                    "value": "6",
                    "groupId": "BG007"
                  }
                ]
              }
            ]
          },
          {
            "title": "Grade II",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "19",
                    "groupId": "BG005"
                  },
                  {
                    "value": "14",
                    "groupId": "BG006"
                  },
                  {
                    "value": "58",
                    "groupId": "BG007"
                  }
                ]
              }
            ],
            "categories": [
              {
                "measurements": [
                  {
                    "value": "2",
                    "groupId": "BG000"
                  },
                  {
                    "value": "4",
                    "groupId": "BG001"
                  },
                  {
                    "value": "2",
                    "groupId": "BG002"
                  },
                  {
                    "value": "3",
                    "groupId": "BG003"
                  },
                  {
                    "value": "2",
                    "groupId": "BG004"
                  },
                  {
                    "value": "9",
                    "groupId": "BG005"
                  },
                  {
                    "value": "4",
                    "groupId": "BG006"
                  },
                  {
                    "value": "26",
                    "groupId": "BG007"
                  }
                ]
              }
            ]
          },
          {
            "title": "Grade III",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "19",
                    "groupId": "BG005"
                  },
                  {
                    "value": "14",
                    "groupId": "BG006"
                  },
                  {
                    "value": "58",
                    "groupId": "BG007"
                  }
                ]
              }
            ],
            "categories": [
              {
                "measurements": [
                  {
                    "value": "3",
                    "groupId": "BG000"
                  },
                  {
                    "value": "1",
                    "groupId": "BG001"
                  },
                  {
                    "value": "2",
                    "groupId": "BG002"
                  },
                  {
                    "value": "2",
                    "groupId": "BG003"
                  },
                  {
                    "value": "3",
                    "groupId": "BG004"
                  },
                  {
                    "value": "8",
                    "groupId": "BG005"
                  },
                  {
                    "value": "6",
                    "groupId": "BG006"
                  },
                  {
                    "value": "25",
                    "groupId": "BG007"
                  }
                ]
              }
            ]
          },
          {
            "title": "Grade X (Unknown)",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "19",
                    "groupId": "BG005"
                  },
                  {
                    "value": "14",
                    "groupId": "BG006"
                  },
                  {
                    "value": "58",
                    "groupId": "BG007"
                  }
                ]
              }
            ],
            "categories": [
              {
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  },
                  {
                    "value": "0",
                    "groupId": "BG003"
                  },
                  {
                    "value": "0",
                    "groupId": "BG004"
                  },
                  {
                    "value": "0",
                    "groupId": "BG005"
                  },
                  {
                    "value": "1",
                    "groupId": "BG006"
                  },
                  {
                    "value": "1",
                    "groupId": "BG007"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "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>",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Tumor Type",
        "classes": [
          {
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG001"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  },
                  {
                    "value": "5",
                    "groupId": "BG003"
                  },
                  {
                    "value": "5",
                    "groupId": "BG004"
                  },
                  {
                    "value": "19",
                    "groupId": "BG005"
                  },
                  {
                    "value": "14",
                    "groupId": "BG006"
                  },
                  {
                    "value": "58",
                    "groupId": "BG007"
                  }
                ]
              }
            ],
            "categories": [
              {
                "title": "Luminal A",
                "measurements": [
                  {
                    "value": "2",
                    "groupId": "BG000"
                  },
                  {
                    "value": "4",
                    "groupId": "BG001"
                  },
                  {
                    "value": "3",
                    "groupId": "BG002"
                  },
                  {
                    "value": "2",
                    "groupId": "BG003"
                  },
                  {
                    "value": "1",
                    "groupId": "BG004"
                  },
                  {
                    "value": "0",
                    "groupId": "BG005"
                  },
                  {
                    "value": "0",
                    "groupId": "BG006"
                  },
                  {
                    "value": "12",
                    "groupId": "BG007"
                  }
                ]
              },
              {
                "title": "Luminal B",
                "measurements": [
                  {
                    "value": "3",
                    "groupId": "BG000"
                  },
                  {
                    "value": "1",
                    "groupId": "BG001"
                  },
                  {
                    "value": "2",
                    "groupId": "BG002"
                  },
                  {
                    "value": "3",
                    "groupId": "BG003"
                  },
                  {
                    "value": "4",
                    "groupId": "BG004"
                  },
                  {
                    "value": "0",
                    "groupId": "BG005"
                  },
                  {
                    "value": "0",
                    "groupId": "BG006"
                  },
                  {
                    "value": "13",
                    "groupId": "BG007"
                  }
                ]
              },
              {
                "title": "Not collected",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  },
                  {
                    "value": "0",
                    "groupId": "BG003"
                  },
                  {
                    "value": "0",
                    "groupId": "BG004"
                  },
                  {
                    "value": "19",
                    "groupId": "BG005"
                  },
                  {
                    "value": "14",
                    "groupId": "BG006"
                  },
                  {
                    "value": "33",
                    "groupId": "BG007"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "description": "Luminal A or B tumor type",
        "unitOfMeasure": "Participants"
      }
    ]
  }
}
Raw JSON 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&#x2F;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&#x2F;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&#x27;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&#x2F; 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&#x2F; 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&#x2F; 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&#x2F; 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&#x2F; 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&#x2F; 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&#x2F; 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&#x2F; 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"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/1",
    "value": {
      "name": "Doxorubicin",
      "type": "DRUG",
      "description": "Doxorubicin (60 mg&#x2F;m2) and cyclophosphamide (600 mg&#x2F;m2) (AC) will be administered concurrently every three weeks for four cycles followed by docetaxel (75 mg&#x2F;m2) every three weeks for four cycles.",
      "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"
      ]
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/2",
    "value": {
      "name": "Cyclophosphamide",
      "type": "DRUG",
      "description": "Doxorubicin (60 mg&#x2F;m2) and cyclophosphamide (600 mg&#x2F;m2) (AC) will be administered concurrently every three weeks for four cycles followed by docetaxel (75 mg&#x2F;m2) every three weeks for four cycles.",
      "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"
      ]
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/3",
    "value": {
      "name": "Docetaxel",
      "type": "DRUG",
      "description": "<p>Doxorubicin (60 mg&#x2F;m2) and cyclophosphamide (600 mg&#x2F;m2) (AC) will be administered concurrently every three weeks for four cycles followed by docetaxel (75 mg&#x2F;m2) every three weeks for four cycles.</p><p>If docetaxel is not tolerated, paclitaxel (175mg&#x2F;m2) may be used in its place.</p>",
      "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"
      ]
    }
  },
  {
    "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&#x2F;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": [
      {
        "measure": "P10s-MAP-Reactive Immunoglobulin Titers",
        "timeFrame": "Week 1 through Week 70",
        "description": "The anti-P10s binding level was measured via ELISA method after incubation with a subject&#x27;s serum or plasma sample.\nData was collected at multiple timepoints throughout the study.\nValues were averaged for each group."
      },
      {
        "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&#x27;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 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&#x27;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 NKp46",
        "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&#x27;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."
      }
    ]
  },
  {
    "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"
  },
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    "value": 425384
  },
  {
    "op": "replace",
    "path": "/hasResults",
    "value": true
  },
  {
    "op": "add",
    "path": "/resultsSection",
    "value": {
      "moreInfoModule": {
        "pointOfContact": {
          "email": "SBLo@uams.edu",
          "phone": "5016868274",
          "title": "Sorena Lo",
          "organization": "University of Arkansas for Medical Sciences"
        },
        "certainAgreement": {
          "piSponsorEmployee": true
        }
      },
      "adverseEventsModule": {
        "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.",
        "eventGroups": [
          {
            "id": "EG000",
            "title": "Part 1 - Chemovax Schedule A",
            "description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE&#x2F;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&#x2F; 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>",
            "otherNumAtRisk": 5,
            "deathsNumAtRisk": 5,
            "otherNumAffected": 5,
            "seriousNumAtRisk": 5,
            "deathsNumAffected": 0,
            "seriousNumAffected": 4
          },
          {
            "id": "EG001",
            "title": "Part 1 - Chemovax Schedule B",
            "description": "<p>Feasibility - Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE&#x2F;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&#x2F; 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>",
            "otherNumAtRisk": 5,
            "deathsNumAtRisk": 5,
            "otherNumAffected": 5,
            "seriousNumAtRisk": 5,
            "deathsNumAffected": 0,
            "seriousNumAffected": 4
          },
          {
            "id": "EG002",
            "title": "Part 1 - Chemovax Schedule C",
            "description": "<p>Feasibility - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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>",
            "otherNumAtRisk": 5,
            "deathsNumAtRisk": 5,
            "otherNumAffected": 5,
            "seriousNumAtRisk": 5,
            "deathsNumAffected": 0,
            "seriousNumAffected": 3
          },
          {
            "id": "EG003",
            "title": "Part 1 - Chemovax Schedule D",
            "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&#x2F;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&#x2F; 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>",
            "otherNumAtRisk": 5,
            "deathsNumAtRisk": 5,
            "otherNumAffected": 5,
            "seriousNumAtRisk": 5,
            "deathsNumAffected": 0,
            "seriousNumAffected": 1
          },
          {
            "id": "EG004",
            "title": "Part 1 - Chemovax Schedule E",
            "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&#x2F;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&#x2F; 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>",
            "otherNumAtRisk": 5,
            "deathsNumAtRisk": 5,
            "otherNumAffected": 5,
            "seriousNumAtRisk": 5,
            "deathsNumAffected": 0,
            "seriousNumAffected": 3
          },
          {
            "id": "EG005",
            "title": "Part 2 &amp; 3 Combined - Chemovax Schedule C",
            "description": "<p>Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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>",
            "otherNumAtRisk": 33,
            "deathsNumAtRisk": 33,
            "otherNumAffected": 33,
            "seriousNumAtRisk": 33,
            "deathsNumAffected": 1,
            "seriousNumAffected": 19
          }
        ],
        "otherEvents": [
          {
            "term": "Anemia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 4,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 5,
                "numEvents": 27,
                "numAffected": 5
              },
              {
                "groupId": "EG002",
                "numAtRisk": 5,
                "numEvents": 11,
                "numAffected": 5
              },
              {
                "groupId": "EG003",
                "numAtRisk": 5,
                "numEvents": 10,
                "numAffected": 3
              },
              {
                "groupId": "EG004",
                "numAtRisk": 5,
                "numEvents": 2,
                "numAffected": 1
              },
              {
                "groupId": "EG005",
                "numAtRisk": 33,
                "numEvents": 144,
                "numAffected": 29
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Blood and lymphatic system disorders - Other, specify",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG002",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG003",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG004",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG005",
                "numAtRisk": 33,
                "numEvents": 4,
                "numAffected": 4
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Atrial fibrillation",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG002",
                "numAtRisk": 5,
                "numEvents": 2,
                "numAffected": 1
              },
              {
                "groupId": "EG003",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG004",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG005",
                "numAtRisk": 33,
                "numEvents": 2,
                "numAffected": 1
              }
            ],
            "organSystem": "Cardiac disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Sinus tachycardia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG002",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG003",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG004",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG005",
                "numAtRisk": 33,
                "numEvents": 3,
                "numAffected": 3
              }
            ],
            "organSystem": "Cardiac disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Ear and labyrinth disorders - Other, specify",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG002",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG003",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG004",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG005",
                "numAtRisk": 33,
                "numEvents": 2,
                "numAffected": 1
              }
            ],
            "organSystem": "Ear and labyrinth disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Ear pain",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG002",
                "numAtRisk": 5,
                "numEvents": 2,
                "numAffected": 2
              },
              {
                "groupId": "EG003",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG004",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG005",
                "numAtRisk": 33,
                "numEvents": 4,
                "numAffected": 4
              }
            ],
            "organSystem": "Ear and labyrinth disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Vertigo",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 2,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG002",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG003",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG004",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG005",
                "numAtRisk": 33,
                "numEvents": 3,
                "numAffected": 1
              }
            ],
            "organSystem": "Ear and labyrinth disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Hypothyroidism",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG002",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG003",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG004",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG005",
                "numAtRisk": 33,
                "numEvents": 6,
                "numAffected": 5
              }
            ],
            "organSystem": "Endocrine disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Blurred vision",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 1,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 5,
                "numEvents": 1,
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              },
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                "groupId": "EG000",
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                "groupId": "EG003",
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                "numAffected": 2
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            ],
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                "numAffected": 1
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              {
                "groupId": "EG001",
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                "groupId": "EG002",
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            ],
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          {
            "term": "Edema limbs",
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                "groupId": "EG000",
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                "numAffected": 1
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              {
                "groupId": "EG001",
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              {
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                "groupId": "EG005",
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                "numAffected": 1
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          {
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                "groupId": "EG000",
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                "groupId": "EG001",
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            "organSystem": "General disorders",
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              {
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          {
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          {
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              {
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              {
                "groupId": "EG002",
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              {
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                "numAffected": 5
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          {
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              {
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              {
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              {
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              {
                "groupId": "EG002",
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              {
                "groupId": "EG002",
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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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          {
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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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            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
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          {
            "term": "Hypertension",
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                "groupId": "EG000",
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              {
                "groupId": "EG001",
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                "numAffected": 2
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              {
                "groupId": "EG002",
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              {
                "groupId": "EG003",
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              },
              {
                "groupId": "EG004",
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                "numEvents": 0,
                "numAffected": 0
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              {
                "groupId": "EG005",
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            ],
            "organSystem": "Vascular disorders",
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          {
            "term": "Thromboembolic event",
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                "groupId": "EG000",
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              {
                "groupId": "EG001",
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                "numEvents": 0,
                "numAffected": 0
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              {
                "groupId": "EG002",
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                "numAffected": 0
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              {
                "groupId": "EG003",
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              {
                "groupId": "EG004",
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                "numAffected": 0
              },
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                "groupId": "EG005",
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            ],
            "organSystem": "Vascular disorders",
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          {
            "term": "Blood and lymphatic system disorders - Other, specify",
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                "groupId": "EG000",
                "numAtRisk": 5,
                "numEvents": 0,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
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                "numEvents": 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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            "organSystem": "Blood and lymphatic system disorders",
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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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            "organSystem": "Cardiac disorders",
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          {
            "term": "Cardia disorders - Other, specify",
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                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "OG000"
                  },
                  {
                    "value": "5",
                    "groupId": "OG001"
                  },
                  {
                    "value": "5",
                    "groupId": "OG002"
                  },
                  {
                    "value": "5",
                    "groupId": "OG003"
                  },
                  {
                    "value": "5",
                    "groupId": "OG004"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Part 1 - Chemovax Schedule A",
                "description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE&#x2F;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&#x2F; 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 B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE&#x2F;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&#x2F; 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 C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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 D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "title": "Greater than or equal to 4-fold increase",
                    "measurements": [
                      {
                        "value": "3",
                        "groupId": "OG000"
                      },
                      {
                        "value": "2",
                        "groupId": "OG001"
                      },
                      {
                        "value": "4",
                        "groupId": "OG002"
                      },
                      {
                        "value": "2",
                        "groupId": "OG003"
                      },
                      {
                        "value": "4",
                        "groupId": "OG004"
                      }
                    ]
                  },
                  {
                    "title": "Less than 4-fold increase",
                    "measurements": [
                      {
                        "value": "2",
                        "groupId": "OG000"
                      },
                      {
                        "value": "3",
                        "groupId": "OG001"
                      },
                      {
                        "value": "1",
                        "groupId": "OG002"
                      },
                      {
                        "value": "3",
                        "groupId": "OG003"
                      },
                      {
                        "value": "1",
                        "groupId": "OG004"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "timeFrame": "At the time of definitive surgery (4-8 weeks after chemo, which is between Week 22 and Week 25)",
            "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>",
            "unitOfMeasure": "Participants",
            "reportingStatus": "POSTED",
            "populationDescription": "This was defined as a &gt;4-fold increase in a subject&#x27;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."
          },
          {
            "type": "PRIMARY",
            "title": "Determine the pCR Rate",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "0",
                    "groupId": "OG000"
                  },
                  {
                    "value": "0",
                    "groupId": "OG001"
                  },
                  {
                    "value": "0",
                    "groupId": "OG002"
                  },
                  {
                    "value": "0",
                    "groupId": "OG003"
                  },
                  {
                    "value": "0",
                    "groupId": "OG004"
                  },
                  {
                    "value": "19",
                    "groupId": "OG005"
                  },
                  {
                    "value": "14",
                    "groupId": "OG006"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Part 1 - Chemovax Schedule A",
                "description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE&#x2F;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&#x2F; 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 B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE&#x2F;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&#x2F; 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 C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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 D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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",
                "description": "<p>Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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>"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "OG000"
                      },
                      {
                        "value": "0",
                        "groupId": "OG001"
                      },
                      {
                        "value": "0",
                        "groupId": "OG002"
                      },
                      {
                        "value": "0",
                        "groupId": "OG003"
                      },
                      {
                        "value": "0",
                        "groupId": "OG004"
                      },
                      {
                        "value": "3",
                        "groupId": "OG005"
                      },
                      {
                        "value": "1",
                        "groupId": "OG006"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "timeFrame": "At the time of definitive surgery (4-8 weeks after chemo, which is between Week 22 and Week 25)",
            "description": "The patient-level primary outcome for this objective is pCR, which is binary yes&#x2F;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.",
            "unitOfMeasure": "Participants",
            "reportingStatus": "POSTED",
            "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&#x27;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."
          },
          {
            "type": "SECONDARY",
            "title": "P10s-MAP-Reactive Immunoglobulin Titers",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "OG000"
                  },
                  {
                    "value": "5",
                    "groupId": "OG001"
                  },
                  {
                    "value": "5",
                    "groupId": "OG002"
                  },
                  {
                    "value": "5",
                    "groupId": "OG003"
                  },
                  {
                    "value": "5",
                    "groupId": "OG004"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Part 1 - Chemovax Schedule A",
                "description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE&#x2F;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&#x2F; 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 B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE&#x2F;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&#x2F; 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 C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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 D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "10.72",
                        "spread": "14.97",
                        "groupId": "OG000"
                      },
                      {
                        "value": "9.76",
                        "spread": "13.91",
                        "groupId": "OG001"
                      },
                      {
                        "value": "42.25",
                        "spread": "71.94",
                        "groupId": "OG002"
                      },
                      {
                        "value": "4.38",
                        "spread": "5.10",
                        "groupId": "OG003"
                      },
                      {
                        "value": "6.74",
                        "spread": "7",
                        "groupId": "OG004"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEAN",
            "timeFrame": "Week 1 through Week 70",
            "description": "The anti-P10s binding level was measured via ELISA method after incubation with a subject&#x27;s serum or plasma sample.\nData was collected at multiple timepoints throughout the study.\nValues were averaged for each group.",
            "unitOfMeasure": "titers",
            "dispersionType": "Standard Deviation",
            "reportingStatus": "POSTED"
          },
          {
            "type": "SECONDARY",
            "title": "Activation Profiles of NK Cells: Pre-Immune and Post-Immune CD16",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "OG000"
                  },
                  {
                    "value": "5",
                    "groupId": "OG001"
                  },
                  {
                    "value": "5",
                    "groupId": "OG002"
                  },
                  {
                    "value": "5",
                    "groupId": "OG003"
                  },
                  {
                    "value": "4",
                    "groupId": "OG004"
                  },
                  {
                    "value": "19",
                    "groupId": "OG005"
                  },
                  {
                    "value": "14",
                    "groupId": "OG006"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Part 1 - Chemovax Schedule A",
                "description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE&#x2F;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&#x2F; 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 B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE&#x2F;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&#x2F; 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 C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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 D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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",
                "description": "<p>Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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>"
              }
            ],
            "classes": [
              {
                "title": "Pre-Immune CD16",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "26065",
                        "spread": "7976.46",
                        "groupId": "OG000"
                      },
                      {
                        "value": "26580",
                        "spread": "2261.51",
                        "groupId": "OG001"
                      },
                      {
                        "value": "25171.8",
                        "spread": "6493",
                        "groupId": "OG002"
                      },
                      {
                        "value": "28546",
                        "spread": "7197.16",
                        "groupId": "OG003"
                      },
                      {
                        "value": "24897",
                        "spread": "5334.72",
                        "groupId": "OG004"
                      },
                      {
                        "value": "67445.83",
                        "spread": "31389.28",
                        "groupId": "OG005"
                      },
                      {
                        "value": "68619.59",
                        "spread": "27944.66",
                        "groupId": "OG006"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Post-Immune CD16",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "19745.4",
                        "spread": "5182.72",
                        "groupId": "OG000"
                      },
                      {
                        "value": "20993.4",
                        "spread": "7061.48",
                        "groupId": "OG001"
                      },
                      {
                        "value": "27998.6",
                        "spread": "10142.41",
                        "groupId": "OG002"
                      },
                      {
                        "value": "22959.8",
                        "spread": "6020.06",
                        "groupId": "OG003"
                      },
                      {
                        "value": "25711.75",
                        "spread": "20572.69",
                        "groupId": "OG004"
                      },
                      {
                        "value": "62323.05",
                        "spread": "24021.75",
                        "groupId": "OG005"
                      },
                      {
                        "value": "65410.12",
                        "spread": "24645.52",
                        "groupId": "OG006"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEAN",
            "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&#x27;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.",
            "unitOfMeasure": "Median Fluorescence Intensity (MFI)",
            "dispersionType": "Standard Deviation",
            "reportingStatus": "POSTED"
          },
          {
            "type": "SECONDARY",
            "title": "Activation Profiles of NK Cells: Pre-Immune and Post-Immune CD69",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "OG000"
                  },
                  {
                    "value": "5",
                    "groupId": "OG001"
                  },
                  {
                    "value": "5",
                    "groupId": "OG002"
                  },
                  {
                    "value": "5",
                    "groupId": "OG003"
                  },
                  {
                    "value": "4",
                    "groupId": "OG004"
                  },
                  {
                    "value": "19",
                    "groupId": "OG005"
                  },
                  {
                    "value": "14",
                    "groupId": "OG006"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Part 1 - Chemovax Schedule A",
                "description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE&#x2F;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&#x2F; 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 B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE&#x2F;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&#x2F; 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 C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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 D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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",
                "description": "<p>Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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>"
              }
            ],
            "classes": [
              {
                "title": "Pre-Immune CD69",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "268.2",
                        "spread": "50.08",
                        "groupId": "OG000"
                      },
                      {
                        "value": "300.8",
                        "spread": "88.02",
                        "groupId": "OG001"
                      },
                      {
                        "value": "291.4",
                        "spread": "38.55",
                        "groupId": "OG002"
                      },
                      {
                        "value": "294.6",
                        "spread": "57.27",
                        "groupId": "OG003"
                      },
                      {
                        "value": "296.25",
                        "spread": "34.37",
                        "groupId": "OG004"
                      },
                      {
                        "value": "428",
                        "spread": "133",
                        "groupId": "OG005"
                      },
                      {
                        "value": "445.5",
                        "spread": "169.17",
                        "groupId": "OG006"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Post-Immune CD69",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "307",
                        "spread": "72.29",
                        "groupId": "OG000"
                      },
                      {
                        "value": "329.6",
                        "spread": "26.23",
                        "groupId": "OG001"
                      },
                      {
                        "value": "275",
                        "spread": "25.25",
                        "groupId": "OG002"
                      },
                      {
                        "value": "278.4",
                        "spread": "27.87",
                        "groupId": "OG003"
                      },
                      {
                        "value": "311.25",
                        "spread": "16.76",
                        "groupId": "OG004"
                      },
                      {
                        "value": "489.44",
                        "spread": "139.9",
                        "groupId": "OG005"
                      },
                      {
                        "value": "505.97",
                        "spread": "161.11",
                        "groupId": "OG006"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEAN",
            "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&#x27;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.",
            "unitOfMeasure": "Median Fluorescence Intensity (MFI)",
            "dispersionType": "Standard Deviation",
            "reportingStatus": "POSTED"
          },
          {
            "type": "SECONDARY",
            "title": "Activation Profiles of NK Cells: Pre-Immune and Post-Immune NKp46",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "5",
                    "groupId": "OG000"
                  },
                  {
                    "value": "5",
                    "groupId": "OG001"
                  },
                  {
                    "value": "5",
                    "groupId": "OG002"
                  },
                  {
                    "value": "5",
                    "groupId": "OG003"
                  },
                  {
                    "value": "4",
                    "groupId": "OG004"
                  },
                  {
                    "value": "19",
                    "groupId": "OG005"
                  },
                  {
                    "value": "14",
                    "groupId": "OG006"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Part 1 - Chemovax Schedule A",
                "description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE&#x2F;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&#x2F; 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 B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE&#x2F;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&#x2F; 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 C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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 D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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",
                "description": "<p>Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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>"
              }
            ],
            "classes": [
              {
                "title": "Pre-Immune NKp46",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "685.2",
                        "spread": "390.469",
                        "groupId": "OG000"
                      },
                      {
                        "value": "590.4",
                        "spread": "204.147",
                        "groupId": "OG001"
                      },
                      {
                        "value": "724.2",
                        "spread": "422.436",
                        "groupId": "OG002"
                      },
                      {
                        "value": "794.2",
                        "spread": "355.618",
                        "groupId": "OG003"
                      },
                      {
                        "value": "744.25",
                        "spread": "251.998",
                        "groupId": "OG004"
                      },
                      {
                        "value": "1360.33",
                        "spread": "638.97",
                        "groupId": "OG005"
                      },
                      {
                        "value": "1650.08",
                        "spread": "878.64",
                        "groupId": "OG006"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Post-Immune NKp46",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1391",
                        "spread": "489.819",
                        "groupId": "OG000"
                      },
                      {
                        "value": "1115.6",
                        "spread": "485.348",
                        "groupId": "OG001"
                      },
                      {
                        "value": "1084.2",
                        "spread": "930.867",
                        "groupId": "OG002"
                      },
                      {
                        "value": "1168.2",
                        "spread": "324.282",
                        "groupId": "OG003"
                      },
                      {
                        "value": "1505.5",
                        "spread": "1031.69",
                        "groupId": "OG004"
                      },
                      {
                        "value": "1412.13",
                        "spread": "645.68",
                        "groupId": "OG005"
                      },
                      {
                        "value": "1813.56",
                        "spread": "879.38",
                        "groupId": "OG006"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEAN",
            "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&#x27;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.",
            "unitOfMeasure": "Median Fluorescence Intensity (MFI)",
            "dispersionType": "Standard Deviation",
            "reportingStatus": "POSTED"
          }
        ]
      },
      "participantFlowModule": {
        "groups": [
          {
            "id": "FG000",
            "title": "Part 1 - Chemovax Schedule A",
            "description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE&#x2F;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&#x2F; 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 B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE&#x2F;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&#x2F; 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 C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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 D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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",
            "description": "<p>Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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>"
          }
        ],
        "periods": [
          {
            "title": "Overall Study",
            "milestones": [
              {
                "type": "STARTED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "5"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "5"
                  },
                  {
                    "groupId": "FG002",
                    "numSubjects": "5"
                  },
                  {
                    "groupId": "FG003",
                    "numSubjects": "5"
                  },
                  {
                    "groupId": "FG004",
                    "numSubjects": "5"
                  },
                  {
                    "groupId": "FG005",
                    "numSubjects": "19"
                  },
                  {
                    "groupId": "FG006",
                    "numSubjects": "14"
                  }
                ]
              },
              {
                "type": "COMPLETED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "4"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "5"
                  },
                  {
                    "groupId": "FG002",
                    "numSubjects": "3"
                  },
                  {
                    "groupId": "FG003",
                    "numSubjects": "3"
                  },
                  {
                    "groupId": "FG004",
                    "numSubjects": "1"
                  },
                  {
                    "groupId": "FG005",
                    "numSubjects": "18"
                  },
                  {
                    "groupId": "FG006",
                    "numSubjects": "10"
                  }
                ]
              },
              {
                "type": "NOT COMPLETED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "1"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "0"
                  },
                  {
                    "groupId": "FG002",
                    "numSubjects": "2"
                  },
                  {
                    "groupId": "FG003",
                    "numSubjects": "2"
                  },
                  {
                    "groupId": "FG004",
                    "numSubjects": "4"
                  },
                  {
                    "groupId": "FG005",
                    "numSubjects": "1"
                  },
                  {
                    "groupId": "FG006",
                    "numSubjects": "4"
                  }
                ]
              }
            ],
            "dropWithdraws": [
              {
                "type": "Adverse Event",
                "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": "Lost to Follow-up",
                "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": "Physician Decision",
                "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": "Withdrawal by Subject",
                "reasons": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "0"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "0"
                  },
                  {
                    "groupId": "FG002",
                    "numSubjects": "1"
                  },
                  {
                    "groupId": "FG003",
                    "numSubjects": "0"
                  },
                  {
                    "groupId": "FG004",
                    "numSubjects": "1"
                  },
                  {
                    "groupId": "FG005",
                    "numSubjects": "1"
                  },
                  {
                    "groupId": "FG006",
                    "numSubjects": "1"
                  }
                ]
              },
              {
                "type": "Death",
                "reasons": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "0"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "0"
                  },
                  {
                    "groupId": "FG002",
                    "numSubjects": "0"
                  },
                  {
                    "groupId": "FG003",
                    "numSubjects": "0"
                  },
                  {
                    "groupId": "FG004",
                    "numSubjects": "0"
                  },
                  {
                    "groupId": "FG005",
                    "numSubjects": "0"
                  },
                  {
                    "groupId": "FG006",
                    "numSubjects": "1"
                  }
                ]
              }
            ]
          }
        ],
        "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."
      },
      "baselineCharacteristicsModule": {
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "5",
                "groupId": "BG000"
              },
              {
                "value": "5",
                "groupId": "BG001"
              },
              {
                "value": "5",
                "groupId": "BG002"
              },
              {
                "value": "5",
                "groupId": "BG003"
              },
              {
                "value": "5",
                "groupId": "BG004"
              },
              {
                "value": "19",
                "groupId": "BG005"
              },
              {
                "value": "14",
                "groupId": "BG006"
              },
              {
                "value": "58",
                "groupId": "BG007"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "BG000",
            "title": "Part 1 - Chemovax Schedule A",
            "description": "<p>Feasibility - Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of P10s-PADRE&#x2F;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&#x2F; 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 B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of P10s-PADRE&#x2F;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&#x2F; 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 C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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 D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Feasibility - Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the P10s-PADRE&#x2F;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&#x2F; 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>Primary Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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": "<p>Expanded Efficacy - Chemovax Schedule C: Subjects will receive three weekly injections of P10s-PADRE&#x2F;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&#x2F; 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": "BG007",
            "title": "Total",
            "description": "Total of all reporting groups"
          }
        ],
        "measures": [
          {
            "title": "Age, Categorical",
            "classes": [
              {
                "denoms": [
                  {
                    "units": "Participants",
                    "counts": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "19",
                        "groupId": "BG005"
                      },
                      {
                        "value": "14",
                        "groupId": "BG006"
                      },
                      {
                        "value": "58",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ],
                "categories": [
                  {
                    "title": "&lt;=18 years",
                    "measurements": [
                      {
                        "value": "0",
                        "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"
                      }
                    ]
                  },
                  {
                    "title": "Between 18 and 65 years",
                    "measurements": [
                      {
                        "value": "4",
                        "groupId": "BG000"
                      },
                      {
                        "value": "4",
                        "groupId": "BG001"
                      },
                      {
                        "value": "4",
                        "groupId": "BG002"
                      },
                      {
                        "value": "3",
                        "groupId": "BG003"
                      },
                      {
                        "value": "4",
                        "groupId": "BG004"
                      },
                      {
                        "value": "17",
                        "groupId": "BG005"
                      },
                      {
                        "value": "13",
                        "groupId": "BG006"
                      },
                      {
                        "value": "49",
                        "groupId": "BG007"
                      }
                    ]
                  },
                  {
                    "title": "&gt;=65 years",
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "BG000"
                      },
                      {
                        "value": "1",
                        "groupId": "BG001"
                      },
                      {
                        "value": "1",
                        "groupId": "BG002"
                      },
                      {
                        "value": "2",
                        "groupId": "BG003"
                      },
                      {
                        "value": "1",
                        "groupId": "BG004"
                      },
                      {
                        "value": "2",
                        "groupId": "BG005"
                      },
                      {
                        "value": "1",
                        "groupId": "BG006"
                      },
                      {
                        "value": "9",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "unitOfMeasure": "Participants"
          },
          {
            "title": "Age, Continuous",
            "classes": [
              {
                "denoms": [
                  {
                    "units": "Participants",
                    "counts": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "19",
                        "groupId": "BG005"
                      },
                      {
                        "value": "14",
                        "groupId": "BG006"
                      },
                      {
                        "value": "58",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ],
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "59",
                        "spread": "12.37",
                        "groupId": "BG000"
                      },
                      {
                        "value": "53",
                        "spread": "10.2",
                        "groupId": "BG001"
                      },
                      {
                        "value": "57.6",
                        "spread": "11.69",
                        "groupId": "BG002"
                      },
                      {
                        "value": "54.8",
                        "spread": "15.42",
                        "groupId": "BG003"
                      },
                      {
                        "value": "43.4",
                        "spread": "15.24",
                        "groupId": "BG004"
                      },
                      {
                        "value": "52.58",
                        "spread": "10.73",
                        "groupId": "BG005"
                      },
                      {
                        "value": "46.86",
                        "spread": "10.73",
                        "groupId": "BG006"
                      },
                      {
                        "value": "50.15",
                        "spread": "10.94",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEAN",
            "unitOfMeasure": "years",
            "dispersionType": "STANDARD_DEVIATION"
          },
          {
            "title": "Sex: Female, Male",
            "classes": [
              {
                "denoms": [
                  {
                    "units": "Participants",
                    "counts": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "19",
                        "groupId": "BG005"
                      },
                      {
                        "value": "14",
                        "groupId": "BG006"
                      },
                      {
                        "value": "58",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ],
                "categories": [
                  {
                    "title": "Female",
                    "measurements": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "19",
                        "groupId": "BG005"
                      },
                      {
                        "value": "14",
                        "groupId": "BG006"
                      },
                      {
                        "value": "58",
                        "groupId": "BG007"
                      }
                    ]
                  },
                  {
                    "title": "Male",
                    "measurements": [
                      {
                        "value": "0",
                        "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"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "unitOfMeasure": "Participants"
          },
          {
            "title": "Ethnicity (NIH&#x2F;OMB)",
            "classes": [
              {
                "denoms": [
                  {
                    "units": "Participants",
                    "counts": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "19",
                        "groupId": "BG005"
                      },
                      {
                        "value": "14",
                        "groupId": "BG006"
                      },
                      {
                        "value": "58",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ],
                "categories": [
                  {
                    "title": "Hispanic or Latino",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG001"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      },
                      {
                        "value": "0",
                        "groupId": "BG003"
                      },
                      {
                        "value": "0",
                        "groupId": "BG004"
                      },
                      {
                        "value": "0",
                        "groupId": "BG005"
                      },
                      {
                        "value": "2",
                        "groupId": "BG006"
                      },
                      {
                        "value": "2",
                        "groupId": "BG007"
                      }
                    ]
                  },
                  {
                    "title": "Not Hispanic or Latino",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG001"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      },
                      {
                        "value": "0",
                        "groupId": "BG003"
                      },
                      {
                        "value": "0",
                        "groupId": "BG004"
                      },
                      {
                        "value": "10",
                        "groupId": "BG005"
                      },
                      {
                        "value": "6",
                        "groupId": "BG006"
                      },
                      {
                        "value": "16",
                        "groupId": "BG007"
                      }
                    ]
                  },
                  {
                    "title": "Unknown or Not Reported",
                    "measurements": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "9",
                        "groupId": "BG005"
                      },
                      {
                        "value": "6",
                        "groupId": "BG006"
                      },
                      {
                        "value": "40",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "unitOfMeasure": "Participants"
          },
          {
            "title": "Race&#x2F;Ethnicity, Customized",
            "classes": [
              {
                "title": "American Indian or Alaska Native",
                "denoms": [
                  {
                    "units": "Participants",
                    "counts": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "19",
                        "groupId": "BG005"
                      },
                      {
                        "value": "14",
                        "groupId": "BG006"
                      },
                      {
                        "value": "58",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ],
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "0",
                        "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"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Asian",
                "denoms": [
                  {
                    "units": "Participants",
                    "counts": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "19",
                        "groupId": "BG005"
                      },
                      {
                        "value": "14",
                        "groupId": "BG006"
                      },
                      {
                        "value": "58",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ],
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "1",
                        "groupId": "BG001"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      },
                      {
                        "value": "0",
                        "groupId": "BG003"
                      },
                      {
                        "value": "0",
                        "groupId": "BG004"
                      },
                      {
                        "value": "0",
                        "groupId": "BG005"
                      },
                      {
                        "value": "1",
                        "groupId": "BG006"
                      },
                      {
                        "value": "2",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Native Hawaiian or Pacific Islander",
                "denoms": [
                  {
                    "units": "Participants",
                    "counts": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "19",
                        "groupId": "BG005"
                      },
                      {
                        "value": "14",
                        "groupId": "BG006"
                      },
                      {
                        "value": "58",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ],
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "0",
                        "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"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Black or African American",
                "denoms": [
                  {
                    "units": "Participants",
                    "counts": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "19",
                        "groupId": "BG005"
                      },
                      {
                        "value": "14",
                        "groupId": "BG006"
                      },
                      {
                        "value": "58",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ],
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "1",
                        "groupId": "BG001"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      },
                      {
                        "value": "0",
                        "groupId": "BG003"
                      },
                      {
                        "value": "0",
                        "groupId": "BG004"
                      },
                      {
                        "value": "5",
                        "groupId": "BG005"
                      },
                      {
                        "value": "3",
                        "groupId": "BG006"
                      },
                      {
                        "value": "9",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "White",
                "denoms": [
                  {
                    "units": "Participants",
                    "counts": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "19",
                        "groupId": "BG005"
                      },
                      {
                        "value": "14",
                        "groupId": "BG006"
                      },
                      {
                        "value": "58",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ],
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "3",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "14",
                        "groupId": "BG005"
                      },
                      {
                        "value": "8",
                        "groupId": "BG006"
                      },
                      {
                        "value": "45",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Other",
                "denoms": [
                  {
                    "units": "Participants",
                    "counts": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "19",
                        "groupId": "BG005"
                      },
                      {
                        "value": "14",
                        "groupId": "BG006"
                      },
                      {
                        "value": "58",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ],
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG001"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      },
                      {
                        "value": "0",
                        "groupId": "BG003"
                      },
                      {
                        "value": "0",
                        "groupId": "BG004"
                      },
                      {
                        "value": "0",
                        "groupId": "BG005"
                      },
                      {
                        "value": "2",
                        "groupId": "BG006"
                      },
                      {
                        "value": "2",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "More than one race",
                "denoms": [
                  {
                    "units": "Participants",
                    "counts": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "19",
                        "groupId": "BG005"
                      },
                      {
                        "value": "14",
                        "groupId": "BG006"
                      },
                      {
                        "value": "58",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ],
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "0",
                        "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"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Unknown or Not Reported",
                "denoms": [
                  {
                    "units": "Participants",
                    "counts": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "19",
                        "groupId": "BG005"
                      },
                      {
                        "value": "14",
                        "groupId": "BG006"
                      },
                      {
                        "value": "58",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ],
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "0",
                        "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"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "unitOfMeasure": "Participants"
          },
          {
            "title": "Region of Enrollment",
            "classes": [
              {
                "title": "United States",
                "denoms": [
                  {
                    "units": "Participants",
                    "counts": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "19",
                        "groupId": "BG005"
                      },
                      {
                        "value": "14",
                        "groupId": "BG006"
                      },
                      {
                        "value": "58",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ],
                "categories": [
                  {
                    "title": "Central Arkansas at University of Arkansas for Medical Sciences",
                    "measurements": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "2",
                        "groupId": "BG002"
                      },
                      {
                        "value": "1",
                        "groupId": "BG003"
                      },
                      {
                        "value": "0",
                        "groupId": "BG004"
                      },
                      {
                        "value": "10",
                        "groupId": "BG005"
                      },
                      {
                        "value": "14",
                        "groupId": "BG006"
                      },
                      {
                        "value": "37",
                        "groupId": "BG007"
                      }
                    ]
                  },
                  {
                    "title": "Northwest Arkansas at Highlands Oncology Group",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG001"
                      },
                      {
                        "value": "3",
                        "groupId": "BG002"
                      },
                      {
                        "value": "4",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "9",
                        "groupId": "BG005"
                      },
                      {
                        "value": "0",
                        "groupId": "BG006"
                      },
                      {
                        "value": "21",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "unitOfMeasure": "Participants"
          },
          {
            "title": "Eastern Cooperative Oncology Group (ECOG) Performance Status",
            "classes": [
              {
                "title": "0 Fully active, able to carry on all pre-disease",
                "denoms": [
                  {
                    "units": "Participants",
                    "counts": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "19",
                        "groupId": "BG005"
                      },
                      {
                        "value": "14",
                        "groupId": "BG006"
                      },
                      {
                        "value": "58",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ],
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "4",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "4",
                        "groupId": "BG003"
                      },
                      {
                        "value": "4",
                        "groupId": "BG004"
                      },
                      {
                        "value": "18",
                        "groupId": "BG005"
                      },
                      {
                        "value": "13",
                        "groupId": "BG006"
                      },
                      {
                        "value": "53",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "1 Restricted in physically strenuous activity but ambulatory and able to carry out work",
                "denoms": [
                  {
                    "units": "Participants",
                    "counts": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "19",
                        "groupId": "BG005"
                      },
                      {
                        "value": "14",
                        "groupId": "BG006"
                      },
                      {
                        "value": "58",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ],
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG001"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      },
                      {
                        "value": "1",
                        "groupId": "BG003"
                      },
                      {
                        "value": "1",
                        "groupId": "BG004"
                      },
                      {
                        "value": "1",
                        "groupId": "BG005"
                      },
                      {
                        "value": "1",
                        "groupId": "BG006"
                      },
                      {
                        "value": "5",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "description": "Measure of how cancer affects a person&#x27;s day-to-day life (https:&#x2F;&#x2F;ecog-acrin.org&#x2F;resources&#x2F;ecog-performance-status&#x2F;).\nIn this study, having a score of 0-1 was a criterion for eligibility.",
            "unitOfMeasure": "Participants",
            "populationDescription": "For 1 participant in Part 2, ECOG Performance was not given."
          },
          {
            "title": "Pre-Treatment Tumor Size",
            "classes": [
              {
                "denoms": [
                  {
                    "units": "Participants",
                    "counts": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "19",
                        "groupId": "BG005"
                      },
                      {
                        "value": "13",
                        "groupId": "BG006"
                      },
                      {
                        "value": "57",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ],
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "2.9",
                        "spread": ".84",
                        "groupId": "BG000"
                      },
                      {
                        "value": "4.06",
                        "spread": "1.44",
                        "groupId": "BG001"
                      },
                      {
                        "value": "4.82",
                        "spread": "2.03",
                        "groupId": "BG002"
                      },
                      {
                        "value": "3.76",
                        "spread": "2.56",
                        "groupId": "BG003"
                      },
                      {
                        "value": "1.96",
                        "spread": "0.82",
                        "groupId": "BG004"
                      },
                      {
                        "value": "4.13",
                        "spread": "2.67",
                        "groupId": "BG005"
                      },
                      {
                        "value": "5.43",
                        "spread": "2.19",
                        "groupId": "BG006"
                      },
                      {
                        "value": "4.03",
                        "spread": "2.38",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEAN",
            "description": "Length of longest diameter of tumor measured in centimeters.",
            "unitOfMeasure": "centimeters",
            "dispersionType": "STANDARD_DEVIATION",
            "populationDescription": "For 1 participant in Part 3, pre-treatment tumor size was not reported."
          },
          {
            "title": "American Joint Committee on Cancer (AJCC) Tumor Staging",
            "classes": [
              {
                "denoms": [
                  {
                    "units": "Participants",
                    "counts": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "18",
                        "groupId": "BG005"
                      },
                      {
                        "value": "14",
                        "groupId": "BG006"
                      },
                      {
                        "value": "57",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ],
                "categories": [
                  {
                    "title": "Stage IA",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG001"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      },
                      {
                        "value": "1",
                        "groupId": "BG003"
                      },
                      {
                        "value": "1",
                        "groupId": "BG004"
                      },
                      {
                        "value": "2",
                        "groupId": "BG005"
                      },
                      {
                        "value": "0",
                        "groupId": "BG006"
                      },
                      {
                        "value": "4",
                        "groupId": "BG007"
                      }
                    ]
                  },
                  {
                    "title": "Stage IB",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG001"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      },
                      {
                        "value": "0",
                        "groupId": "BG003"
                      },
                      {
                        "value": "0",
                        "groupId": "BG004"
                      },
                      {
                        "value": "0",
                        "groupId": "BG005"
                      },
                      {
                        "value": "1",
                        "groupId": "BG006"
                      },
                      {
                        "value": "1",
                        "groupId": "BG007"
                      }
                    ]
                  },
                  {
                    "title": "Stage II",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG001"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      },
                      {
                        "value": "1",
                        "groupId": "BG003"
                      },
                      {
                        "value": "0",
                        "groupId": "BG004"
                      },
                      {
                        "value": "1",
                        "groupId": "BG005"
                      },
                      {
                        "value": "3",
                        "groupId": "BG006"
                      },
                      {
                        "value": "5",
                        "groupId": "BG007"
                      }
                    ]
                  },
                  {
                    "title": "Stage IIA",
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "BG000"
                      },
                      {
                        "value": "2",
                        "groupId": "BG001"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      },
                      {
                        "value": "1",
                        "groupId": "BG003"
                      },
                      {
                        "value": "1",
                        "groupId": "BG004"
                      },
                      {
                        "value": "4",
                        "groupId": "BG005"
                      },
                      {
                        "value": "2",
                        "groupId": "BG006"
                      },
                      {
                        "value": "11",
                        "groupId": "BG007"
                      }
                    ]
                  },
                  {
                    "title": "Stage IIB",
                    "measurements": [
                      {
                        "value": "3",
                        "groupId": "BG000"
                      },
                      {
                        "value": "1",
                        "groupId": "BG001"
                      },
                      {
                        "value": "2",
                        "groupId": "BG002"
                      },
                      {
                        "value": "1",
                        "groupId": "BG003"
                      },
                      {
                        "value": "2",
                        "groupId": "BG004"
                      },
                      {
                        "value": "4",
                        "groupId": "BG005"
                      },
                      {
                        "value": "4",
                        "groupId": "BG006"
                      },
                      {
                        "value": "17",
                        "groupId": "BG007"
                      }
                    ]
                  },
                  {
                    "title": "Stage III",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG001"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      },
                      {
                        "value": "1",
                        "groupId": "BG003"
                      },
                      {
                        "value": "0",
                        "groupId": "BG004"
                      },
                      {
                        "value": "3",
                        "groupId": "BG005"
                      },
                      {
                        "value": "2",
                        "groupId": "BG006"
                      },
                      {
                        "value": "6",
                        "groupId": "BG007"
                      }
                    ]
                  },
                  {
                    "title": "Stage IIIA",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "1",
                        "groupId": "BG001"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      },
                      {
                        "value": "0",
                        "groupId": "BG003"
                      },
                      {
                        "value": "0",
                        "groupId": "BG004"
                      },
                      {
                        "value": "2",
                        "groupId": "BG005"
                      },
                      {
                        "value": "1",
                        "groupId": "BG006"
                      },
                      {
                        "value": "4",
                        "groupId": "BG007"
                      }
                    ]
                  },
                  {
                    "title": "Stage IIIB",
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "BG000"
                      },
                      {
                        "value": "1",
                        "groupId": "BG001"
                      },
                      {
                        "value": "2",
                        "groupId": "BG002"
                      },
                      {
                        "value": "0",
                        "groupId": "BG003"
                      },
                      {
                        "value": "1",
                        "groupId": "BG004"
                      },
                      {
                        "value": "2",
                        "groupId": "BG005"
                      },
                      {
                        "value": "1",
                        "groupId": "BG006"
                      },
                      {
                        "value": "8",
                        "groupId": "BG007"
                      }
                    ]
                  },
                  {
                    "title": "Stage not reported&#x2F;given",
                    "measurements": [
                      {
                        "value": "0",
                        "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"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_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>",
            "unitOfMeasure": "Participants",
            "populationDescription": "For 2 participants, both in Part 2, AJCC stage was not given."
          },
          {
            "title": "Tumor Grade",
            "classes": [
              {
                "title": "Grade I",
                "denoms": [
                  {
                    "units": "Participants",
                    "counts": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "19",
                        "groupId": "BG005"
                      },
                      {
                        "value": "14",
                        "groupId": "BG006"
                      },
                      {
                        "value": "58",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ],
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG001"
                      },
                      {
                        "value": "1",
                        "groupId": "BG002"
                      },
                      {
                        "value": "0",
                        "groupId": "BG003"
                      },
                      {
                        "value": "0",
                        "groupId": "BG004"
                      },
                      {
                        "value": "2",
                        "groupId": "BG005"
                      },
                      {
                        "value": "3",
                        "groupId": "BG006"
                      },
                      {
                        "value": "6",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Grade II",
                "denoms": [
                  {
                    "units": "Participants",
                    "counts": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "19",
                        "groupId": "BG005"
                      },
                      {
                        "value": "14",
                        "groupId": "BG006"
                      },
                      {
                        "value": "58",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ],
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "2",
                        "groupId": "BG000"
                      },
                      {
                        "value": "4",
                        "groupId": "BG001"
                      },
                      {
                        "value": "2",
                        "groupId": "BG002"
                      },
                      {
                        "value": "3",
                        "groupId": "BG003"
                      },
                      {
                        "value": "2",
                        "groupId": "BG004"
                      },
                      {
                        "value": "9",
                        "groupId": "BG005"
                      },
                      {
                        "value": "4",
                        "groupId": "BG006"
                      },
                      {
                        "value": "26",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Grade III",
                "denoms": [
                  {
                    "units": "Participants",
                    "counts": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "19",
                        "groupId": "BG005"
                      },
                      {
                        "value": "14",
                        "groupId": "BG006"
                      },
                      {
                        "value": "58",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ],
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "3",
                        "groupId": "BG000"
                      },
                      {
                        "value": "1",
                        "groupId": "BG001"
                      },
                      {
                        "value": "2",
                        "groupId": "BG002"
                      },
                      {
                        "value": "2",
                        "groupId": "BG003"
                      },
                      {
                        "value": "3",
                        "groupId": "BG004"
                      },
                      {
                        "value": "8",
                        "groupId": "BG005"
                      },
                      {
                        "value": "6",
                        "groupId": "BG006"
                      },
                      {
                        "value": "25",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Grade X (Unknown)",
                "denoms": [
                  {
                    "units": "Participants",
                    "counts": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "19",
                        "groupId": "BG005"
                      },
                      {
                        "value": "14",
                        "groupId": "BG006"
                      },
                      {
                        "value": "58",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ],
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG001"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      },
                      {
                        "value": "0",
                        "groupId": "BG003"
                      },
                      {
                        "value": "0",
                        "groupId": "BG004"
                      },
                      {
                        "value": "0",
                        "groupId": "BG005"
                      },
                      {
                        "value": "1",
                        "groupId": "BG006"
                      },
                      {
                        "value": "1",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "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>",
            "unitOfMeasure": "Participants"
          },
          {
            "title": "Tumor Type",
            "classes": [
              {
                "denoms": [
                  {
                    "units": "Participants",
                    "counts": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG001"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      },
                      {
                        "value": "5",
                        "groupId": "BG003"
                      },
                      {
                        "value": "5",
                        "groupId": "BG004"
                      },
                      {
                        "value": "19",
                        "groupId": "BG005"
                      },
                      {
                        "value": "14",
                        "groupId": "BG006"
                      },
                      {
                        "value": "58",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ],
                "categories": [
                  {
                    "title": "Luminal A",
                    "measurements": [
                      {
                        "value": "2",
                        "groupId": "BG000"
                      },
                      {
                        "value": "4",
                        "groupId": "BG001"
                      },
                      {
                        "value": "3",
                        "groupId": "BG002"
                      },
                      {
                        "value": "2",
                        "groupId": "BG003"
                      },
                      {
                        "value": "1",
                        "groupId": "BG004"
                      },
                      {
                        "value": "0",
                        "groupId": "BG005"
                      },
                      {
                        "value": "0",
                        "groupId": "BG006"
                      },
                      {
                        "value": "12",
                        "groupId": "BG007"
                      }
                    ]
                  },
                  {
                    "title": "Luminal B",
                    "measurements": [
                      {
                        "value": "3",
                        "groupId": "BG000"
                      },
                      {
                        "value": "1",
                        "groupId": "BG001"
                      },
                      {
                        "value": "2",
                        "groupId": "BG002"
                      },
                      {
                        "value": "3",
                        "groupId": "BG003"
                      },
                      {
                        "value": "4",
                        "groupId": "BG004"
                      },
                      {
                        "value": "0",
                        "groupId": "BG005"
                      },
                      {
                        "value": "0",
                        "groupId": "BG006"
                      },
                      {
                        "value": "13",
                        "groupId": "BG007"
                      }
                    ]
                  },
                  {
                    "title": "Not collected",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG001"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      },
                      {
                        "value": "0",
                        "groupId": "BG003"
                      },
                      {
                        "value": "0",
                        "groupId": "BG004"
                      },
                      {
                        "value": "19",
                        "groupId": "BG005"
                      },
                      {
                        "value": "14",
                        "groupId": "BG006"
                      },
                      {
                        "value": "33",
                        "groupId": "BG007"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "description": "Luminal A or B tumor type",
            "unitOfMeasure": "Participants"
          }
        ]
      }
    }
  }
]