Evidence Record
evt_NCT03414684_v18_v19_78b730a04e1c
NCT03414684 · Carboplatin +/- Nivolumab in Metastatic Triple Negative Breast Cancer
Superseded Evidence Record
This page preserves the immutable v0.1.2 record. Its current successor is evt_NCT03414684_v18_v19_4f6d615a8de6.
Severity is deterministic, reproducible, uncalibrated triage metadata, not validated review priority or proven wrongdoing. This page states what the registry evidence supports and what it does not support.
Triage severity
Triage: Low Category
Results Reconciliation
Versions
v18 to v19
Timing
Late Recruitment
Claims Supported
- TrialDiff compared ClinicalTrials.gov record version 18 to version 19 for NCT03414684.
- The JSON Patch for this comparison has hash 14d1bb5d4595926e7c348023be1739ea1fc85f4d73bc81b40d81fc81350cb2b7.
- The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.
- The deterministic triage label was low; before timing adjustment it was low.
- The triage label is uncalibrated metadata, not a validated review-priority finding.
- The patch satisfied these deterministic event-class predicates: outcome_edit_cooccurs_with_results_posting.
- The timing context for the from-version record was late_recruitment.
- The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorFullName, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/2/measure, /protocolSection/outcomesModule/secondaryOutcomes/2/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/3/measure, /protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/4/measure, /protocolSection/outcomesModule/secondaryOutcomes/4/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/5/measure, /protocolSection/outcomesModule/secondaryOutcomes/5/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/6/measure, /protocolSection/outcomesModule/secondaryOutcomes/6/description, /protocolSection/outcomesModule/secondaryOutcomes/6/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/7/measure, /protocolSection/outcomesModule/secondaryOutcomes/7/description, /protocolSection/outcomesModule/secondaryOutcomes/7/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/8/measure, /protocolSection/outcomesModule/secondaryOutcomes/8/description, /protocolSection/outcomesModule/secondaryOutcomes/8/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/9, /protocolSection/outcomesModule/secondaryOutcomes/10, /protocolSection/outcomesModule/secondaryOutcomes/11, /protocolSection/outcomesModule/secondaryOutcomes/12, /protocolSection/outcomesModule/secondaryOutcomes/13, /protocolSection/outcomesModule/secondaryOutcomes/14, /protocolSection/outcomesModule/secondaryOutcomes/15, /protocolSection/outcomesModule/secondaryOutcomes/16, /protocolSection/outcomesModule/secondaryOutcomes/17, /protocolSection/outcomesModule/secondaryOutcomes/18, /protocolSection/outcomesModule/secondaryOutcomes/19, /protocolSection/outcomesModule/secondaryOutcomes/20, /hasResults, /resultsSection, /annotationSection, /documentSection.
- An outcome path changed between versions 18 and 19 in a patch that also carried a hasResults or resultsSection co-occurrence signal.
Claims Not Supported
- That the amendment was scientifically unjustified.
- That the change constitutes misconduct or wrongdoing.
- That sponsor intent can be inferred from this registry change.
- That the change caused or altered the trial's results.
- That the change was or was not disclosed in a manuscript.
- That TrialDiff determines regulatory compliance or non-compliance.
- That co-occurrence with results posting proves the outcome edit was harmless, administrative, or substantively benign.
- That event-class membership is a validated global review-priority ranking.
Neutral Review Question
What source document explains this registry amendment, and does it change interpretation of the trial record?
Citation
TrialDiff Evidence Record evt_NCT03414684_v18_v19_78b730a04e1c. ClinicalTrials.gov NCT03414684, versions 18-19. Evidence version 1.
Event Classes
outcome_edit_cooccurs_with_results_posting Changed Paths
/protocolSection/statusModule/statusVerifiedDate
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/resultsFirstSubmitDate
/protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorFullName
/protocolSection/outcomesModule/primaryOutcomes/0/measure
/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit
/protocolSection/outcomesModule/secondaryOutcomes/0/measure
/protocolSection/outcomesModule/secondaryOutcomes/0/reviewUnit
/protocolSection/outcomesModule/secondaryOutcomes/1/measure
/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit
/protocolSection/outcomesModule/secondaryOutcomes/2/measure
/protocolSection/outcomesModule/secondaryOutcomes/2/reviewUnit
/protocolSection/outcomesModule/secondaryOutcomes/3/measure
/protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit
/protocolSection/outcomesModule/secondaryOutcomes/4/measure
/protocolSection/outcomesModule/secondaryOutcomes/4/reviewUnit
/protocolSection/outcomesModule/secondaryOutcomes/5/measure
/protocolSection/outcomesModule/secondaryOutcomes/5/reviewUnit
/protocolSection/outcomesModule/secondaryOutcomes/6/measure
/protocolSection/outcomesModule/secondaryOutcomes/6/description
/protocolSection/outcomesModule/secondaryOutcomes/6/reviewUnit
/protocolSection/outcomesModule/secondaryOutcomes/7/measure
/protocolSection/outcomesModule/secondaryOutcomes/7/description
/protocolSection/outcomesModule/secondaryOutcomes/7/reviewUnit
/protocolSection/outcomesModule/secondaryOutcomes/8/measure
/protocolSection/outcomesModule/secondaryOutcomes/8/description
/protocolSection/outcomesModule/secondaryOutcomes/8/reviewUnit
/protocolSection/outcomesModule/secondaryOutcomes/9
/protocolSection/outcomesModule/secondaryOutcomes/10
/protocolSection/outcomesModule/secondaryOutcomes/11
/protocolSection/outcomesModule/secondaryOutcomes/12
/protocolSection/outcomesModule/secondaryOutcomes/13
/protocolSection/outcomesModule/secondaryOutcomes/14
/protocolSection/outcomesModule/secondaryOutcomes/15
/protocolSection/outcomesModule/secondaryOutcomes/16
/protocolSection/outcomesModule/secondaryOutcomes/17
/protocolSection/outcomesModule/secondaryOutcomes/18
/protocolSection/outcomesModule/secondaryOutcomes/19
/protocolSection/outcomesModule/secondaryOutcomes/20
/hasResults
/resultsSection
/annotationSection
/documentSection
View the field-level diff for before/after values on each changed path.
Deterministic Rules
No deterministic rules recorded.
Provenance
- Package generation
v0.1.2- Succeeded by
- evt_NCT03414684_v18_v19_4f6d615a8de6
- Patch hash
14d1bb5d4595926e7c348023be1739ea1fc85f4d73bc81b40d81fc81350cb2b7- Canonical hash
17ad32b0dd154e34c9b18939ebbc97e6bd27031f236ff743731de86263b23ff0- Rule set hash
318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86- From snapshot
9fa55a73afa002e423d266b3f6067fb920b17b4fdc15609d85b43b2a75daf45a- To snapshot
fbbd246670b4f76e23446c0c26cb932b89232471a2fc7a338f3a4b5d9c79beaf- Patch source
- ctgov_internal_history
- Generated at
- 2026-07-31T00:42:12.000Z
- Source URL
- Registry payload
Canonical JSON Preview
Stored payload{
"changed_paths": [
"/protocolSection/statusModule/statusVerifiedDate",
"/protocolSection/statusModule/lastUpdateSubmitDate",
"/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"/protocolSection/statusModule/resultsFirstSubmitDate",
"/protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorFullName",
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/0/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/2/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/4/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/5/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/6/description",
"/protocolSection/outcomesModule/secondaryOutcomes/6/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/7/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/7/description",
"/protocolSection/outcomesModule/secondaryOutcomes/7/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/8/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/8/description",
"/protocolSection/outcomesModule/secondaryOutcomes/8/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/9",
"/protocolSection/outcomesModule/secondaryOutcomes/10",
"/protocolSection/outcomesModule/secondaryOutcomes/11",
"/protocolSection/outcomesModule/secondaryOutcomes/12",
"/protocolSection/outcomesModule/secondaryOutcomes/13",
"/protocolSection/outcomesModule/secondaryOutcomes/14",
"/protocolSection/outcomesModule/secondaryOutcomes/15",
"/protocolSection/outcomesModule/secondaryOutcomes/16",
"/protocolSection/outcomesModule/secondaryOutcomes/17",
"/protocolSection/outcomesModule/secondaryOutcomes/18",
"/protocolSection/outcomesModule/secondaryOutcomes/19",
"/protocolSection/outcomesModule/secondaryOutcomes/20",
"/hasResults",
"/resultsSection",
"/annotationSection",
"/documentSection"
],
"citation_text": "TrialDiff Evidence Record evt_NCT03414684_v18_v19_78b730a04e1c. ClinicalTrials.gov NCT03414684, versions 18-19. Evidence version 1.",
"claims_not_supported": [
"That the amendment was scientifically unjustified.",
"That the change constitutes misconduct or wrongdoing.",
"That sponsor intent can be inferred from this registry change.",
"That the change caused or altered the trial's results.",
"That the change was or was not disclosed in a manuscript.",
"That TrialDiff determines regulatory compliance or non-compliance.",
"That co-occurrence with results posting proves the outcome edit was harmless, administrative, or substantively benign.",
"That event-class membership is a validated global review-priority ranking."
],
"claims_supported": [
"TrialDiff compared ClinicalTrials.gov record version 18 to version 19 for NCT03414684.",
"The JSON Patch for this comparison has hash 14d1bb5d4595926e7c348023be1739ea1fc85f4d73bc81b40d81fc81350cb2b7.",
"The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.",
"The deterministic triage label was low; before timing adjustment it was low.",
"The triage label is uncalibrated metadata, not a validated review-priority finding.",
"The patch satisfied these deterministic event-class predicates: outcome_edit_cooccurs_with_results_posting.",
"The timing context for the from-version record was late_recruitment.",
"The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorFullName, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/2/measure, /protocolSection/outcomesModule/secondaryOutcomes/2/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/3/measure, /protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/4/measure, /protocolSection/outcomesModule/secondaryOutcomes/4/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/5/measure, /protocolSection/outcomesModule/secondaryOutcomes/5/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/6/measure, /protocolSection/outcomesModule/secondaryOutcomes/6/description, /protocolSection/outcomesModule/secondaryOutcomes/6/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/7/measure, /protocolSection/outcomesModule/secondaryOutcomes/7/description, /protocolSection/outcomesModule/secondaryOutcomes/7/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/8/measure, /protocolSection/outcomesModule/secondaryOutcomes/8/description, /protocolSection/outcomesModule/secondaryOutcomes/8/reviewUnit, /protocolSection/outcomesModule/secondaryOutcomes/9, /protocolSection/outcomesModule/secondaryOutcomes/10, /protocolSection/outcomesModule/secondaryOutcomes/11, /protocolSection/outcomesModule/secondaryOutcomes/12, /protocolSection/outcomesModule/secondaryOutcomes/13, /protocolSection/outcomesModule/secondaryOutcomes/14, /protocolSection/outcomesModule/secondaryOutcomes/15, /protocolSection/outcomesModule/secondaryOutcomes/16, /protocolSection/outcomesModule/secondaryOutcomes/17, /protocolSection/outcomesModule/secondaryOutcomes/18, /protocolSection/outcomesModule/secondaryOutcomes/19, /protocolSection/outcomesModule/secondaryOutcomes/20, /hasResults, /resultsSection, /annotationSection, /documentSection.",
"An outcome path changed between versions 18 and 19 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
],
"classification": {
"calibration_status": "uncalibrated",
"categories": [
"results_reconciliation"
],
"category": "results_reconciliation",
"deterministic_rules": [],
"event_class_rule_set_hash": "07957f8b90549d4f42387f51b471ecde9901b6db63bbc27b84c73631603407c0",
"event_classes": [
"outcome_edit_cooccurs_with_results_posting"
],
"rule_set_hash": "318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86",
"severity": "low",
"severity_pre_timing": "low",
"timing_context": "late_recruitment",
"triage_label": "low",
"triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
"value_signals": [
{
"category": "results_reconciliation",
"paths": [
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/0/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/10",
"/protocolSection/outcomesModule/secondaryOutcomes/11",
"/protocolSection/outcomesModule/secondaryOutcomes/12",
"/protocolSection/outcomesModule/secondaryOutcomes/13",
"/protocolSection/outcomesModule/secondaryOutcomes/14",
"/protocolSection/outcomesModule/secondaryOutcomes/15",
"/protocolSection/outcomesModule/secondaryOutcomes/16",
"/protocolSection/outcomesModule/secondaryOutcomes/17",
"/protocolSection/outcomesModule/secondaryOutcomes/18",
"/protocolSection/outcomesModule/secondaryOutcomes/19",
"/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/2/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/20",
"/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/4/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/5/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/6/description",
"/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/6/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/7/description",
"/protocolSection/outcomesModule/secondaryOutcomes/7/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/7/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/8/description",
"/protocolSection/outcomesModule/secondaryOutcomes/8/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/8/reviewUnit",
"/protocolSection/outcomesModule/secondaryOutcomes/9"
],
"severity": "low",
"signal": "results_reconciliation_outcome_suppression"
}
]
},
"event_id": "evt_NCT03414684_v18_v19_78b730a04e1c",
"evidence_version": 1,
"patch": [
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2022-11"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2022-11-11"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2022-12-12"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2022-11-11"
},
{
"op": "replace",
"path": "/protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorFullName",
"value": "Sara Tolaney, MD"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Progression-free Survival"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
"value": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame.",
"One or more of these comments also apply to other measures in the record."
]
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Objective Response Rate by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/reviewUnit",
"value": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"value": "Objective Response Rate by Immune-Related Response Criteria (irRC)"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
"value": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"value": "Overall Survival"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/reviewUnit",
"value": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"value": "Clinical Benefit Rate"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit",
"value": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
"value": "Duration of Response"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/reviewUnit",
"value": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
"value": "Time to Objective Response"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/reviewUnit",
"value": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
"value": "Progression-free Survival Among PD-L1-positive Patients"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/description",
"value": "<p>PFS defined as the time from randomization (or registration) to the earlier of progression or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation.</p><p>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/reviewUnit",
"value": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/7/measure",
"value": "Objective Response Rate by RECIST 1.1 Among PD-L1-positive Patients"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/7/description",
"value": "<p>ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1.</p><p>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/7/reviewUnit",
"value": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/8/measure",
"value": "Objective Response Rate by irRC Among PD-L1-positive Patients"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/8/description",
"value": "<p>ORR by irRC defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters [irSPD] of 50% or greater) based on irRC.</p><p>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/8/reviewUnit",
"value": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/9",
"value": {
"description": "<p>OS defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive.</p><p>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>",
"measure": "Overall Survival Among PD-L1-positive Patients",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/10",
"value": {
"description": "<p>CBR defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks.</p><p>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>",
"measure": "Clinical Benefit Rate Among PD-L1-positive Patients",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/11",
"value": {
"description": "<p>DOR defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.\nPatients without events reported are censored at the last disease evaluation.</p><p>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>",
"measure": "Duration of Response Among PD-L1-positive Patients",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/12",
"value": {
"description": "<p>TTOR defined as the time from registration to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded.</p><p>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>",
"measure": "Time to Objective Response Among PD-L1-positive Patients",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/13",
"value": {
"description": "PFS defined as the time from the start of crossover treatment to the earlier of progression (on second-course therapy) or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation.",
"measure": "Second-course Progression-free Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/14",
"value": {
"description": "ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1.,\nduring second-course therapy",
"measure": "Second-course Objective Response Rate by RECIST 1.1 Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/15",
"value": {
"description": "ORR by irRC defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters [irSPD] of 50% or greater) based on irRC, during second-course therapy",
"measure": "Second-course Objective Response Rate by irRC Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/16",
"value": {
"description": "CBR defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks, during second course therapy",
"measure": "Second-course Clinical Benefit Rate Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/17",
"value": {
"description": "DOR defined as the time measurement criteria are met for second-course CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented thereafter.\nPatients without events reported are censored at the last disease evaluation.",
"measure": "Second-course Duration of Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/18",
"value": {
"description": "TTOR defined as the time from start of crossover treatment to the date of the first documented CR or PR by RECIST 1.1 on second-course therapy, whichever is first recorded",
"measure": "Second-course Time to Objective Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/19",
"value": {
"description": "Second-course OS defined as the time from the start of crossover treatment to death due from any cause, or censored at date last known alive.",
"measure": "Second-course Overall Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/20",
"value": {
"description": "PFS, ORR according to RECIST 1.1 and irRC, CBR, DOR, TTOR and OS, among patients with germline BRCA1 or BRCA2 mutations (all efficacy endpoints defined as above)",
"measure": "Efficacy Among BRCA-mutant Patients",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years"
}
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"adverseEventsModule": {
"description": "<p>An SAE is any untoward medical occurrence that:</p><ul><li>results in death</li><li>is life-threatening (i.e., participant was at risk of death at the time of the event)</li><li>requires hospitalization or prolongs existing hospitalization</li><li>results in persistent/significant disability/incapacity</li><li>is a congenital anomaly/birth defect</li><li>is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)</li></ul>",
"eventGroups": [
{
"deathsNumAffected": 24,
"deathsNumAtRisk": 37,
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>",
"id": "EG000",
"otherNumAffected": 37,
"otherNumAtRisk": 37,
"seriousNumAffected": 10,
"seriousNumAtRisk": 37,
"title": "Arm A: Carboplatin + Nivolumab"
},
{
"deathsNumAffected": 17,
"deathsNumAtRisk": 38,
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"id": "EG001",
"otherNumAffected": 38,
"otherNumAtRisk": 38,
"seriousNumAffected": 11,
"seriousNumAtRisk": 38,
"title": "Arm B: Carboplatin"
},
{
"deathsNumAffected": 10,
"deathsNumAtRisk": 18,
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"id": "EG002",
"otherNumAffected": 18,
"otherNumAtRisk": 18,
"seriousNumAffected": 6,
"seriousNumAtRisk": 18,
"title": "Arm B: Carboplatin -- Crossover"
}
],
"frequencyThreshold": "5",
"otherEvents": [
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 25,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 20,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 8,
"numAtRisk": 18
}
],
"term": "Anemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 4,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 2,
"numAtRisk": 18
}
],
"term": "Blood and lymphatic system disorders - Other, specify"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 2,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 18
}
],
"term": "Atrial fibrillation"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Ear and labyrinth disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 4,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 18
}
],
"term": "Tinnitus"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Endocrine disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 11,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 3,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 2,
"numAtRisk": 18
}
],
"term": "Hypothyroidism"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Eye disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 18
}
],
"term": "Blurred vision"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 2,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 3,
"numAtRisk": 18
}
],
"term": "Abdominal pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 18
}
],
"term": "Colitis"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 18,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 14,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 4,
"numAtRisk": 18
}
],
"term": "Constipation"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 11,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 7,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 9,
"numAtRisk": 18
}
],
"term": "Diarrhea"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 3,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 2,
"numAtRisk": 18
}
],
"term": "Gastroesophageal reflux disease"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 18
}
],
"term": "Hemorrhoids"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 18
}
],
"term": "Mucositis oral"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 21,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 26,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 7,
"numAtRisk": 18
}
],
"term": "Nausea"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 8,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 3,
"numAtRisk": 18
}
],
"term": "Vomiting"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 18
}
],
"term": "Chills"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 5,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 18
}
],
"term": "Edema limbs"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 28,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 28,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 11,
"numAtRisk": 18
}
],
"term": "Fatigue"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 5,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 5,
"numAtRisk": 18
}
],
"term": "Fever"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 8,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 18
}
],
"term": "Infusion related reaction"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 3,
"numAtRisk": 18
}
],
"term": "Localized edema"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 18
}
],
"term": "Non-cardiac chest pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 10,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 13,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 4,
"numAtRisk": 18
}
],
"term": "Pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 2,
"numAtRisk": 18
}
],
"term": "Infections and infestations - Other, specify"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 18
}
],
"term": "Lung infection"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 18
}
],
"term": "Sinusitis"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 3,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 18
}
],
"term": "Skin infection"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 3,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 18
}
],
"term": "Upper respiratory infection"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 18
}
],
"term": "Urinary tract infection"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 18
}
],
"term": "Vaginal infection"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Injury, poisoning and procedural complications",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 18
}
],
"term": "Bruising"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 6,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 3,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 2,
"numAtRisk": 18
}
],
"term": "Alanine aminotransferase increased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 6,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 3,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 2,
"numAtRisk": 18
}
],
"term": "Alkaline phosphatase increased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 7,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 3,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 3,
"numAtRisk": 18
}
],
"term": "Aspartate aminotransferase increased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 18
}
],
"term": "Blood bilirubin increased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 2,
"numAtRisk": 18
}
],
"term": "Creatinine increased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 37
},
{
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"numAtRisk": 38
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{
"groupId": "EG002",
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"term": "Investigations - Other, specify"
},
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"groupId": "EG002",
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"term": "Lymphocyte count decreased"
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"term": "Neutrophil count decreased"
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"groupId": "EG001",
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{
"groupId": "EG002",
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"term": "Platelet count decreased"
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{
"groupId": "EG001",
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"groupId": "EG002",
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"term": "Weight loss"
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"groupId": "EG002",
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"term": "White blood cell decreased"
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"term": "Anorexia"
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"groupId": "EG002",
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"term": "Dehydration"
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"groupId": "EG002",
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"term": "Hyperglycemia"
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"groupId": "EG002",
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"term": "Hypoalbuminemia"
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"groupId": "EG002",
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"term": "Hypocalcemia"
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"term": "Hypokalemia"
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"term": "Hypomagnesemia"
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"groupId": "EG001",
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"groupId": "EG002",
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"term": "Hyponatremia"
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"groupId": "EG001",
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"groupId": "EG002",
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],
"term": "Hypophosphatemia"
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"groupId": "EG001",
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"groupId": "EG002",
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"term": "Metabolism and nutrition disorders - Other, specify"
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{
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{
"groupId": "EG001",
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"groupId": "EG002",
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"term": "Arthralgia"
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{
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"term": "Back pain"
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"groupId": "EG002",
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"term": "Bone pain"
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{
"groupId": "EG001",
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"groupId": "EG002",
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"term": "Chest wall pain"
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"groupId": "EG001",
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"groupId": "EG002",
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"term": "Generalized muscle weakness"
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"groupId": "EG002",
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"term": "Myalgia"
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"groupId": "EG002",
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"term": "Neck pain"
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"groupId": "EG001",
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"groupId": "EG002",
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],
"term": "Pain in extremity"
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{
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"groupId": "EG001",
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"groupId": "EG002",
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],
"term": "Dizziness"
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{
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"groupId": "EG002",
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"term": "Headache"
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"groupId": "EG002",
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"term": "Peripheral sensory neuropathy"
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"groupId": "EG002",
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],
"term": "Tremor"
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{
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"groupId": "EG002",
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"term": "Anxiety"
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],
"term": "Depression"
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{
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"term": "Insomnia"
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"term": "Breast pain"
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{
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{
"groupId": "EG001",
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"groupId": "EG002",
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"numAtRisk": 18
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],
"term": "Cough"
},
{
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{
"groupId": "EG001",
"numAffected": 17,
"numAtRisk": 38
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{
"groupId": "EG002",
"numAffected": 7,
"numAtRisk": 18
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],
"term": "Dyspnea"
},
{
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"groupId": "EG001",
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"groupId": "EG002",
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],
"term": "Epistaxis"
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{
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"groupId": "EG002",
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"term": "Nasal congestion"
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"groupId": "EG002",
"numAffected": 4,
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],
"term": "Pneumonitis"
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"groupId": "EG001",
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"numAtRisk": 38
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"groupId": "EG002",
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],
"term": "Sore throat"
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{
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"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 38
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"groupId": "EG002",
"numAffected": 0,
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"term": "Wheezing"
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{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 38
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{
"groupId": "EG002",
"numAffected": 5,
"numAtRisk": 18
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],
"term": "Alopecia"
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{
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{
"groupId": "EG001",
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"groupId": "EG002",
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"term": "Dry skin"
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{
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{
"groupId": "EG001",
"numAffected": 0,
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"groupId": "EG002",
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"numAtRisk": 18
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"term": "Pruritus"
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{
"groupId": "EG001",
"numAffected": 2,
"numAtRisk": 38
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{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 18
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],
"term": "Rash acneiform"
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{
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{
"groupId": "EG001",
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"groupId": "EG002",
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"term": "Rash maculo-papular"
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"groupId": "EG001",
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"groupId": "EG002",
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"term": "Skin/subcutaneous tissue disorders; Other, specify"
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{
"groupId": "EG001",
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"groupId": "EG002",
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"term": "Flushing"
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{
"groupId": "EG001",
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"groupId": "EG002",
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"term": "Hot flashes"
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{
"groupId": "EG001",
"numAffected": 6,
"numAtRisk": 38
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"groupId": "EG002",
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],
"term": "Hypertension"
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"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 18
}
],
"term": "Cough"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 18
}
],
"term": "Pleural effusion"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 18
}
],
"term": "Enterocolitis"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 18
}
],
"term": "Small intestinal obstruction"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 18
}
],
"term": "Flu like symptoms"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Injury, poisoning and procedural complications",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 18
}
],
"term": "Spinal fracture"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE (4.0)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 37
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 38
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 18
}
],
"term": "Pneumonitis"
}
],
"timeFrame": "Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab."
},
"baselineCharacteristicsModule": {
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "37"
},
{
"groupId": "BG001",
"value": "38"
},
{
"groupId": "BG002",
"value": "75"
}
],
"units": "Participants"
}
],
"groups": [
{
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>",
"id": "BG000",
"title": "Arm A: Carboplatin + Nivolumab"
},
{
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"id": "BG001",
"title": "Arm B: Carboplatin"
},
{
"description": "Total of all reporting groups",
"id": "BG002",
"title": "Total"
}
],
"measures": [
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"lowerLimit": "27.9",
"upperLimit": "75.8",
"value": "59.1"
},
{
"groupId": "BG001",
"lowerLimit": "25.4",
"upperLimit": "75.5",
"value": "59.1"
},
{
"groupId": "BG002",
"lowerLimit": "25.4",
"upperLimit": "75.8",
"value": "59.1"
}
]
}
]
}
],
"dispersionType": "FULL_RANGE",
"paramType": "MEDIAN",
"title": "Age, Continuous",
"unitOfMeasure": "years"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "1"
},
{
"groupId": "BG001",
"value": "4"
},
{
"groupId": "BG002",
"value": "5"
}
],
"title": "<40"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "19"
},
{
"groupId": "BG001",
"value": "16"
},
{
"groupId": "BG002",
"value": "35"
}
],
"title": "40-59"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "17"
},
{
"groupId": "BG001",
"value": "18"
},
{
"groupId": "BG002",
"value": "35"
}
],
"title": ">=60"
}
],
"title": "Age, years"
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Age, Customized",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "37"
},
{
"groupId": "BG001",
"value": "38"
},
{
"groupId": "BG002",
"value": "75"
}
],
"title": "Female"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
}
],
"title": "Male"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Sex: Female, Male",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "2"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "2"
}
],
"title": "Hispanic or Latino"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "33"
},
{
"groupId": "BG001",
"value": "36"
},
{
"groupId": "BG002",
"value": "69"
}
],
"title": "Not Hispanic or Latino"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "2"
},
{
"groupId": "BG001",
"value": "2"
},
{
"groupId": "BG002",
"value": "4"
}
],
"title": "Unknown or Not Reported"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Ethnicity (NIH/OMB)",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "1"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "1"
}
],
"title": "Asian"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "2"
},
{
"groupId": "BG001",
"value": "3"
},
{
"groupId": "BG002",
"value": "5"
}
],
"title": "Black or African American"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "30"
},
{
"groupId": "BG001",
"value": "34"
},
{
"groupId": "BG002",
"value": "64"
}
],
"title": "Caucasian"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "1"
},
{
"groupId": "BG001",
"value": "1"
},
{
"groupId": "BG002",
"value": "2"
}
],
"title": "More than one race"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "3"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "3"
}
],
"title": "Other"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Race/Ethnicity, Customized",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "1"
},
{
"groupId": "BG001",
"value": "2"
},
{
"groupId": "BG002",
"value": "3"
}
],
"title": "gBRCA1 mutation"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "1"
},
{
"groupId": "BG002",
"value": "1"
}
],
"title": "gBRCA2 mutation"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "36"
},
{
"groupId": "BG001",
"value": "35"
},
{
"groupId": "BG002",
"value": "71"
}
],
"title": "Non-gBRCA1/2 carrier"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Germline BRCA Status",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "6"
},
{
"groupId": "BG001",
"value": "6"
},
{
"groupId": "BG002",
"value": "12"
}
],
"title": "Positive"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "11"
},
{
"groupId": "BG001",
"value": "12"
},
{
"groupId": "BG002",
"value": "23"
}
],
"title": "Negative"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "20"
},
{
"groupId": "BG001",
"value": "20"
},
{
"groupId": "BG002",
"value": "40"
}
],
"title": "Not done"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) Status -- Local",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "14"
},
{
"groupId": "BG001",
"value": "14"
},
{
"groupId": "BG002",
"value": "28"
}
],
"title": "Positive (>=1% IC)"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "23"
},
{
"groupId": "BG001",
"value": "24"
},
{
"groupId": "BG002",
"value": "47"
}
],
"title": "Negative (<1% IC)"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) Status -- Central, SP142",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "1"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "1"
}
],
"title": "0%"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "23"
},
{
"groupId": "BG001",
"value": "19"
},
{
"groupId": "BG002",
"value": "42"
}
],
"title": "1-9%"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "11"
},
{
"groupId": "BG001",
"value": "17"
},
{
"groupId": "BG002",
"value": "28"
}
],
"title": "10-49%"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "1"
},
{
"groupId": "BG001",
"value": "1"
},
{
"groupId": "BG002",
"value": "2"
}
],
"title": ">=50%"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "1"
},
{
"groupId": "BG001",
"value": "1"
},
{
"groupId": "BG002",
"value": "2"
}
],
"title": "Unknown"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Stromal tumor-infiltrating lymphocytes (sTILs)",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "28"
},
{
"groupId": "BG001",
"value": "28"
},
{
"groupId": "BG002",
"value": "56"
}
],
"title": "0"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "9"
},
{
"groupId": "BG001",
"value": "10"
},
{
"groupId": "BG002",
"value": "19"
}
],
"title": "1"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"reviewUnit": {
"resetReasons": [
"The description of the scale or categories does not include sufficient information to understand the results reported."
]
},
"title": "Eastern Cooperative Oncology Group (ECOG) Performance Status",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "1"
},
{
"groupId": "BG001",
"value": "3"
},
{
"groupId": "BG002",
"value": "4"
}
],
"title": "Yes"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "36"
},
{
"groupId": "BG001",
"value": "35"
},
{
"groupId": "BG002",
"value": "71"
}
],
"title": "No"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Inflammatory breast cancer",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "1"
},
{
"groupId": "BG001",
"value": "4"
},
{
"groupId": "BG002",
"value": "5"
}
],
"title": "Yes"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "36"
},
{
"groupId": "BG001",
"value": "34"
},
{
"groupId": "BG002",
"value": "70"
}
],
"title": "No"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Prior anthracycline in neoadjuvant/adjuvant setting",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "9"
},
{
"groupId": "BG001",
"value": "10"
},
{
"groupId": "BG002",
"value": "19"
}
],
"title": "Yes"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "28"
},
{
"groupId": "BG001",
"value": "28"
},
{
"groupId": "BG002",
"value": "56"
}
],
"title": "No"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Prior taxane in neoadjuvant/adjuvant setting",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "4"
},
{
"groupId": "BG001",
"value": "3"
},
{
"groupId": "BG002",
"value": "7"
}
],
"title": "Yes"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "33"
},
{
"groupId": "BG001",
"value": "35"
},
{
"groupId": "BG002",
"value": "68"
}
],
"title": "No"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Prior platinum in neoadjuvant/adjuvant setting",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "32"
},
{
"groupId": "BG001",
"value": "30"
},
{
"groupId": "BG002",
"value": "62"
}
],
"title": "0"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "8"
},
{
"groupId": "BG002",
"value": "13"
}
],
"title": "1"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Number of lines of prior chemotherapy for advanced disease",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "23"
},
{
"groupId": "BG001",
"value": "24"
},
{
"groupId": "BG002",
"value": "47"
}
],
"title": "<= Upper Limit of Normal"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "10"
},
{
"groupId": "BG001",
"value": "14"
},
{
"groupId": "BG002",
"value": "24"
}
],
"title": "> Upper Limit of Normal"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "4"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "4"
}
],
"title": "Unknown"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Baseline lactate dehydrogenase (LDH)",
"unitOfMeasure": "Participants"
}
],
"populationDescription": "78 patients were enrolled and randomized, but only 75 patients started protocol therapy.\nThe primary analysis population is the treated population, thus baseline characteristics are shown for the 75 patients that started protocol therapy."
},
"moreInfoModule": {
"certainAgreement": {
"piSponsorEmployee": true
},
"pointOfContact": {
"email": "Sara_Tolaney@dfci.harvard.edu",
"organization": "Dana-Farber Cancer Institute",
"phone": "617-632-5743",
"title": "Sara Tolaney, MD, MPH"
}
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"analyses": [
{
"ciLowerLimit": "0.49",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"ciUpperLimit": "1.84",
"estimateComment": "Reference level is Arm B, such that hazard ratio corresponds to the effect of treatment on Arm A",
"groupIds": [
"OG000",
"OG001"
],
"nonInferiorityType": "SUPERIORITY",
"pValue": "0.88",
"paramType": "Hazard Ratio (HR)",
"paramValue": "0.95",
"statisticalComment": "stratified log rank test",
"statisticalMethod": "Log Rank"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "2.7",
"upperLimit": "11.5",
"value": "4.2"
},
{
"groupId": "OG001",
"lowerLimit": "4.4",
"upperLimit": "19.2",
"value": "5.5"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "32"
},
{
"groupId": "OG001",
"value": "30"
}
],
"units": "Participants"
}
],
"description": "Defined as the time from randomization (or registration) to the earlier of progression or death due to any cause.\nParticipants alive without disease progression are censored at date of last disease evaluation",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>",
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab"
},
{
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"id": "OG001",
"title": "Arm B: Carboplatin"
}
],
"paramType": "MEDIAN",
"populationDescription": "The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment.",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame.",
"One or more of these comments also apply to other measures in the record."
]
},
"timeFrame": "3.5 years",
"title": "Progression-free Survival",
"type": "PRIMARY",
"unitOfMeasure": "months"
},
{
"analyses": [
{
"ciLowerLimit": "0.29",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"ciUpperLimit": "4.18",
"estimateComment": "Reference level is Arm B, such that the odds ratio corresponds to the effect of treatment on Arm A",
"groupIds": [
"OG000",
"OG001"
],
"nonInferiorityType": "SUPERIORITY",
"pValue": "1",
"paramType": "Odds Ratio (OR)",
"paramValue": "1.09",
"statisticalMethod": "Fisher Exact"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "11.5",
"upperLimit": "43.4",
"value": "25.0"
},
{
"groupId": "OG001",
"lowerLimit": "9.9",
"upperLimit": "42.3",
"value": "23.3"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "32"
},
{
"groupId": "OG001",
"value": "30"
}
],
"units": "Participants"
}
],
"description": "Defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>",
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab"
},
{
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"id": "OG001",
"title": "Arm B: Carboplatin"
}
],
"paramType": "NUMBER",
"populationDescription": "The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment.",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years",
"title": "Objective Response Rate by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1",
"type": "SECONDARY",
"unitOfMeasure": "percent of patients achieving response"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "13.7",
"upperLimit": "46.7",
"value": "28.1"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "32"
},
{
"groupId": "OG001",
"value": "0"
}
],
"units": "Participants"
}
],
"description": "Defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters [irSPD] of 50% or greater) based on irRC",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>",
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab"
},
{
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"id": "OG001",
"title": "Arm B: Carboplatin"
}
],
"paramType": "NUMBER",
"populationDescription": "First-course objective response rate by irRC was only evaluated in the 32 patients that received immunotherapy (on Arm A) in the ITT population.\nBecause of this, statistical testing by arm was not performed.",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years",
"title": "Objective Response Rate by Immune-Related Response Criteria (irRC)",
"type": "SECONDARY",
"unitOfMeasure": "percent of patients with IR response"
},
{
"analyses": [
{
"ciLowerLimit": "0.43",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"ciUpperLimit": "1.50",
"estimateComment": "Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A",
"groupIds": [
"OG000",
"OG001"
],
"nonInferiorityType": "SUPERIORITY",
"pValue": "0.49",
"paramType": "Hazard Ratio (HR)",
"paramValue": "0.80",
"statisticalComment": "stratified log rank test",
"statisticalMethod": "Log Rank"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG000",
"lowerLimit": "10.4",
"upperLimit": "NA",
"value": "16.8"
},
{
"groupId": "OG001",
"lowerLimit": "8.2",
"upperLimit": "24.4",
"value": "11.1"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "32"
},
{
"groupId": "OG001",
"value": "30"
}
],
"units": "Participants"
}
],
"description": "Defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>",
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab"
},
{
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"id": "OG001",
"title": "Arm B: Carboplatin"
}
],
"paramType": "MEDIAN",
"populationDescription": "The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment.",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years",
"title": "Overall Survival",
"type": "SECONDARY",
"unitOfMeasure": "months"
},
{
"analyses": [
{
"ciLowerLimit": "0.32",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"ciUpperLimit": "3.43",
"estimateComment": "Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A",
"groupIds": [
"OG000",
"OG001"
],
"nonInferiorityType": "SUPERIORITY",
"pValue": "1",
"paramType": "Odds Ratio (OR)",
"paramValue": "1.05",
"statisticalMethod": "Fisher Exact"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "18.6",
"upperLimit": "53.2",
"value": "34.4"
},
{
"groupId": "OG001",
"lowerLimit": "17.3",
"upperLimit": "52.8",
"value": "33.3"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "32"
},
{
"groupId": "OG001",
"value": "30"
}
],
"units": "Participants"
}
],
"description": "Defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>",
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab"
},
{
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"id": "OG001",
"title": "Arm B: Carboplatin"
}
],
"paramType": "NUMBER",
"populationDescription": "The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment.",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years",
"title": "Clinical Benefit Rate",
"type": "SECONDARY",
"unitOfMeasure": "percent of patients achieving benefit"
},
{
"analyses": [
{
"ciLowerLimit": "0.13",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"ciUpperLimit": "2.12",
"estimateComment": "Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A",
"groupIds": [
"OG000",
"OG001"
],
"nonInferiorityType": "SUPERIORITY",
"pValue": "0.36",
"paramType": "Hazard Ratio (HR)",
"paramValue": "0.53",
"statisticalMethod": "Log Rank"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG000",
"lowerLimit": "16.8",
"upperLimit": "NA",
"value": "19.3"
},
{
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG001",
"lowerLimit": "2.7",
"upperLimit": "NA",
"value": "7.7"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "8"
},
{
"groupId": "OG001",
"value": "7"
}
],
"units": "Participants"
}
],
"description": "Defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.\nPatients without events reported are censored at the last disease evaluation",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>",
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab"
},
{
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"id": "OG001",
"title": "Arm B: Carboplatin"
}
],
"paramType": "MEDIAN",
"populationDescription": "Duration of response was analyzed among the total 15 patients who achieved objective response in the ITT population.",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years",
"title": "Duration of Response",
"type": "SECONDARY",
"unitOfMeasure": "months"
},
{
"analyses": [
{
"ciLowerLimit": "0.43",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"ciUpperLimit": "3.43",
"estimateComment": "Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A",
"groupIds": [
"OG000",
"OG001"
],
"nonInferiorityType": "SUPERIORITY",
"pValue": "0.68",
"paramType": "Hazard Ratio (HR)",
"paramValue": "1.24",
"statisticalMethod": "Log Rank"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG000",
"lowerLimit": "4.0",
"upperLimit": "NA",
"value": "4.6"
},
{
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG001",
"lowerLimit": "4.7",
"upperLimit": "NA",
"value": "11.2"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "32"
},
{
"groupId": "OG001",
"value": "30"
}
],
"units": "Participants"
}
],
"description": "Defined as the time from registration to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>",
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab"
},
{
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"id": "OG001",
"title": "Arm B: Carboplatin"
}
],
"paramType": "MEDIAN",
"populationDescription": "The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment.",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years",
"title": "Time to Objective Response",
"type": "SECONDARY",
"unitOfMeasure": "months"
},
{
"analyses": [
{
"ciLowerLimit": "0.18",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"ciUpperLimit": "1.62",
"estimateComment": "Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A",
"groupIds": [
"OG000",
"OG001"
],
"nonInferiorityType": "SUPERIORITY",
"pValue": "0.27",
"paramType": "Hazard Ratio (HR)",
"paramValue": "0.54",
"statisticalComment": "stratified log rank test",
"statisticalMethod": "Log Rank"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG000",
"lowerLimit": "2.5",
"upperLimit": "NA",
"value": "8.3"
},
{
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG001",
"lowerLimit": "1.6",
"upperLimit": "NA",
"value": "4.7"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "13"
},
{
"groupId": "OG001",
"value": "11"
}
],
"units": "Participants"
}
],
"description": "<p>PFS defined as the time from randomization (or registration) to the earlier of progression or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation.</p><p>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>",
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab"
},
{
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"id": "OG001",
"title": "Arm B: Carboplatin"
}
],
"paramType": "MEDIAN",
"populationDescription": "A total of 24 patients were PD-L1-positive in the ITT population.",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years",
"title": "Progression-free Survival Among PD-L1-positive Patients",
"type": "SECONDARY",
"unitOfMeasure": "months"
},
{
"analyses": [
{
"ciLowerLimit": "0.08",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"ciUpperLimit": "7.78",
"estimateComment": "Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A",
"groupIds": [
"OG000",
"OG001"
],
"nonInferiorityType": "SUPERIORITY",
"pValue": "1",
"paramType": "Odds Ratio (OR)",
"paramValue": "0.81",
"statisticalMethod": "Fisher Exact"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "5.0",
"upperLimit": "53.8",
"value": "23.1"
},
{
"groupId": "OG001",
"lowerLimit": "6.0",
"upperLimit": "61.0",
"value": "27.3"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "13"
},
{
"groupId": "OG001",
"value": "11"
}
],
"units": "Participants"
}
],
"description": "<p>ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1.</p><p>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>",
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab"
},
{
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"id": "OG001",
"title": "Arm B: Carboplatin"
}
],
"paramType": "NUMBER",
"populationDescription": "A total of 24 patients were PD-L1-positive in the ITT population.",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years",
"title": "Objective Response Rate by RECIST 1.1 Among PD-L1-positive Patients",
"type": "SECONDARY",
"unitOfMeasure": "percent of patients achieving response"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "9.1",
"upperLimit": "61.4",
"value": "30.8"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "13"
},
{
"groupId": "OG001",
"value": "0"
}
],
"units": "Participants"
}
],
"description": "<p>ORR by irRC defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters [irSPD] of 50% or greater) based on irRC.</p><p>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>",
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab"
},
{
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"id": "OG001",
"title": "Arm B: Carboplatin"
}
],
"paramType": "NUMBER",
"populationDescription": "A total of 13 patients were treated with immunotherapy (on Arm A) and were PD-L1-positive in the ITT population.\nBecause first-course irORR was only assessed for patients on Arm A, no statistical testing by arm was performed.",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years",
"title": "Objective Response Rate by irRC Among PD-L1-positive Patients",
"type": "SECONDARY",
"unitOfMeasure": "percent of patients with IR response"
},
{
"analyses": [
{
"ciLowerLimit": "0.26",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"ciUpperLimit": "2.16",
"estimateComment": "Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A",
"groupIds": [
"OG000",
"OG001"
],
"nonInferiorityType": "SUPERIORITY",
"pValue": "0.61",
"paramType": "Hazard Ratio (HR)",
"paramValue": "0.75",
"statisticalComment": "stratified log rank test",
"statisticalMethod": "Log Rank"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG000",
"lowerLimit": "4.9",
"upperLimit": "NA",
"value": "17.6"
},
{
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG001",
"lowerLimit": "6.7",
"upperLimit": "NA",
"value": "10.7"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "13"
},
{
"groupId": "OG001",
"value": "11"
}
],
"units": "Participants"
}
],
"description": "<p>OS defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive.</p><p>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>",
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab"
},
{
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"id": "OG001",
"title": "Arm B: Carboplatin"
}
],
"paramType": "MEDIAN",
"populationDescription": "A total of 24 patients were PD-L1-positive in the ITT population.",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years",
"title": "Overall Survival Among PD-L1-positive Patients",
"type": "SECONDARY",
"unitOfMeasure": "months"
},
{
"analyses": [
{
"ciLowerLimit": "0.10",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"ciUpperLimit": "5.93",
"estimateComment": "Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A",
"groupIds": [
"OG000",
"OG001"
],
"nonInferiorityType": "SUPERIORITY",
"pValue": "1",
"paramType": "Odds Ratio (OR)",
"paramValue": "0.79",
"statisticalMethod": "Fisher Exact"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "9.1",
"upperLimit": "61.4",
"value": "30.8"
},
{
"groupId": "OG001",
"lowerLimit": "10.9",
"upperLimit": "69.2",
"value": "36.4"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "13"
},
{
"groupId": "OG001",
"value": "11"
}
],
"units": "Participants"
}
],
"description": "<p>CBR defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks.</p><p>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>",
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab"
},
{
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"id": "OG001",
"title": "Arm B: Carboplatin"
}
],
"paramType": "NUMBER",
"populationDescription": "A total of 24 patients were PD-L1-positive in the ITT population.",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years",
"title": "Clinical Benefit Rate Among PD-L1-positive Patients",
"type": "SECONDARY",
"unitOfMeasure": "percent of patients achieving benefit"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"comment": "Bounds inestimable due to insufficient sample size/number of events",
"groupId": "OG000",
"lowerLimit": "NA",
"upperLimit": "NA",
"value": "16.8"
},
{
"comment": "Upper bound inestimable due to insufficient sample size/number of events",
"groupId": "OG001",
"lowerLimit": "2.0",
"upperLimit": "NA",
"value": "4.9"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "3"
},
{
"groupId": "OG001",
"value": "3"
}
],
"units": "Participants"
}
],
"description": "<p>DOR defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.\nPatients without events reported are censored at the last disease evaluation.</p><p>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>",
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab"
},
{
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"id": "OG001",
"title": "Arm B: Carboplatin"
}
],
"paramType": "MEDIAN",
"populationDescription": "Duration of response was assessed only among the 6 PD-L1-positive patients in the ITT population who achieved objective response.\nDue to insufficient sample size, statistical testing by arm was not performed.",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years",
"title": "Duration of Response Among PD-L1-positive Patients",
"type": "SECONDARY",
"unitOfMeasure": "months"
},
{
"analyses": [
{
"ciLowerLimit": "0.14",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"ciUpperLimit": "3.89",
"estimateComment": "Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A",
"groupIds": [
"OG000",
"OG001"
],
"nonInferiorityType": "SUPERIORITY",
"pValue": "0.73",
"paramType": "Hazard Ratio (HR)",
"paramValue": "0.75",
"statisticalMethod": "Log Rank"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"comment": "Median and upper bound inestimable due to insufficient number of responses",
"groupId": "OG000",
"lowerLimit": "3.4",
"upperLimit": "NA",
"value": "NA"
},
{
"comment": "Median and upper bound inestimable due to insufficient number of responses",
"groupId": "OG001",
"lowerLimit": "3.0",
"upperLimit": "NA",
"value": "NA"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "13"
},
{
"groupId": "OG001",
"value": "11"
}
],
"units": "Participants"
}
],
"description": "<p>TTOR defined as the time from registration to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded.</p><p>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>",
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab"
},
{
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"id": "OG001",
"title": "Arm B: Carboplatin"
}
],
"paramType": "MEDIAN",
"populationDescription": "A total of 24 patients were PD-L1-positive in the ITT population.",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years",
"title": "Time to Objective Response Among PD-L1-positive Patients",
"type": "SECONDARY",
"unitOfMeasure": "months"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"comment": "Upper bound inestimable due to insufficient sample size / number of events",
"groupId": "OG001",
"lowerLimit": "1.9",
"upperLimit": "NA",
"value": "4.1"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "0"
},
{
"groupId": "OG001",
"value": "10"
}
],
"units": "Participants"
}
],
"description": "PFS defined as the time from the start of crossover treatment to the earlier of progression (on second-course therapy) or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation.",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>",
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab"
},
{
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"id": "OG001",
"title": "Arm B: Carboplatin"
}
],
"paramType": "MEDIAN",
"populationDescription": "10 patients in the ITT population who were initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years",
"title": "Second-course Progression-free Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"type": "SECONDARY",
"unitOfMeasure": "months"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG001",
"lowerLimit": "2.5",
"upperLimit": "55.6",
"value": "20.0"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "0"
},
{
"groupId": "OG001",
"value": "10"
}
],
"units": "Participants"
}
],
"description": "ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1.,\nduring second-course therapy",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>",
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab"
},
{
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"id": "OG001",
"title": "Arm B: Carboplatin"
}
],
"paramType": "NUMBER",
"populationDescription": "10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years",
"title": "Second-course Objective Response Rate by RECIST 1.1 Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"type": "SECONDARY",
"unitOfMeasure": "percent of patients achieving response"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG001",
"lowerLimit": "2.5",
"upperLimit": "55.6",
"value": "20.0"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "0"
},
{
"groupId": "OG001",
"value": "10"
}
],
"units": "Participants"
}
],
"description": "ORR by irRC defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters [irSPD] of 50% or greater) based on irRC, during second-course therapy",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>",
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab"
},
{
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"id": "OG001",
"title": "Arm B: Carboplatin"
}
],
"paramType": "NUMBER",
"populationDescription": "10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years",
"title": "Second-course Objective Response Rate by irRC Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"type": "SECONDARY",
"unitOfMeasure": "percent of patients with IR response"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG001",
"lowerLimit": "6.7",
"upperLimit": "65.2",
"value": "30.0"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "0"
},
{
"groupId": "OG001",
"value": "10"
}
],
"units": "Participants"
}
],
"description": "CBR defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks, during second course therapy",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>",
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab"
},
{
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"id": "OG001",
"title": "Arm B: Carboplatin"
}
],
"paramType": "NUMBER",
"populationDescription": "10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years",
"title": "Second-course Clinical Benefit Rate Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"type": "SECONDARY",
"unitOfMeasure": "percent of patients achieving benefit"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"comment": "Upper bound inestimable due to insufficient sample size",
"groupId": "OG001",
"lowerLimit": "1.81",
"upperLimit": "NA",
"value": "1.81"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "0"
},
{
"groupId": "OG001",
"value": "2"
}
],
"units": "Participants"
}
],
"description": "DOR defined as the time measurement criteria are met for second-course CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented thereafter.\nPatients without events reported are censored at the last disease evaluation.",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>",
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab"
},
{
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"id": "OG001",
"title": "Arm B: Carboplatin"
}
],
"paramType": "MEDIAN",
"populationDescription": "10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab, and only 2 of these patients achieved objective response",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years",
"title": "Second-course Duration of Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"type": "SECONDARY",
"unitOfMeasure": "months"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"comment": "Median and upper bound inestimable due to insufficient number of responses",
"groupId": "OG001",
"lowerLimit": "3.5",
"upperLimit": "NA",
"value": "NA"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "0"
},
{
"groupId": "OG001",
"value": "10"
}
],
"units": "Participants"
}
],
"description": "TTOR defined as the time from start of crossover treatment to the date of the first documented CR or PR by RECIST 1.1 on second-course therapy, whichever is first recorded",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>",
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab"
},
{
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"id": "OG001",
"title": "Arm B: Carboplatin"
}
],
"paramType": "MEDIAN",
"populationDescription": "10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years",
"title": "Second-course Time to Objective Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"type": "SECONDARY",
"unitOfMeasure": "months"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG001",
"lowerLimit": "6.4",
"upperLimit": "NA",
"value": "12.9"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "0"
},
{
"groupId": "OG001",
"value": "10"
}
],
"units": "Participants"
}
],
"description": "Second-course OS defined as the time from the start of crossover treatment to death due from any cause, or censored at date last known alive.",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>",
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab"
},
{
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"id": "OG001",
"title": "Arm B: Carboplatin"
}
],
"paramType": "MEDIAN",
"populationDescription": "10 patients in the ITT population who were initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"timeFrame": "3.5 years",
"title": "Second-course Overall Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"type": "SECONDARY",
"unitOfMeasure": "months"
},
{
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "0"
},
{
"groupId": "OG001",
"value": "0"
}
],
"units": "Participants"
}
],
"description": "PFS, ORR according to RECIST 1.1 and irRC, CBR, DOR, TTOR and OS, among patients with germline BRCA1 or BRCA2 mutations (all efficacy endpoints defined as above)",
"groups": [
{
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>",
"id": "OG000",
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},
{
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"measureCategoriesReviewUnit": {
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]
},
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},
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]
},
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"id": "FG000",
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},
{
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},
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{
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"groupId": "FG000",
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},
{
"groupId": "FG001",
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{
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{
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}
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"type": "Adverse Event"
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{
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"groupId": "FG000",
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"type": "Physician Decision"
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{
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{
"reasons": [
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"groupId": "FG000",
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},
{
"groupId": "FG001",
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},
{
"reasons": [
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"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
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}
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"type": ""Participant needed palliative radiation, which is not permitted on study""
},
{
"reasons": [
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"groupId": "FG000",
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},
{
"groupId": "FG001",
"numSubjects": "0"
}
],
"type": "Still on treatment"
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],
"milestones": [
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"achievements": [
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"groupId": "FG000",
"numSubjects": "37"
},
{
"comment": "39 patients were randomized to Arm B, but only 38 started treatment",
"groupId": "FG001",
"numSubjects": "38"
}
],
"type": "STARTED"
},
{
"achievements": [
{
"comment": "<p>There was no completion of treatment, per protocol.\nPatients were to remain on treatment until:</p><ul><li>Disease progression</li><li>Complete response (and treated for at least 24 weeks, with at least two treatments occurring beyond the date when the initial CR was declared)</li><li>Intercurrent illness</li><li>Unacceptable adverse event(s)</li><li>Withdrawal of consent</li><li>General/specific changes in the patient's condition that render the patient unacceptable for further treatment</li></ul>",
"groupId": "FG000",
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},
{
"comment": "<p>There was no completion of treatment, per protocol.\nPatients were to remain on treatment until:</p><ul><li>Disease progression</li><li>Complete response (and treated for at least 24 weeks, with at least two treatments occurring beyond the date when the initial CR was declared)</li><li>Intercurrent illness</li><li>Unacceptable adverse event(s)</li><li>Withdrawal of consent</li><li>General/specific changes in the patient's condition that render the patient unacceptable for further treatment</li></ul>",
"groupId": "FG001",
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"achievements": [
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},
{
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],
"type": "NOT COMPLETED"
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],
"reviewUnit": {
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"title": "First-course Treatment"
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{
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{
"groupId": "FG001",
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"type": "Progressive disease"
},
{
"reasons": [
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},
{
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],
"type": "Adverse Event"
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],
"type": "Physician Decision"
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{
"reasons": [
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"groupId": "FG000",
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{
"groupId": "FG001",
"numSubjects": "2"
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],
"type": "Still on treatment"
}
],
"milestones": [
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"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
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],
"type": "STARTED"
},
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "0"
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{
"comment": "<p>There was no completion of treatment, per protocol.\nPatients were to remain on treatment until:</p><ul><li>Disease progression</li><li>Complete response (and treated for at least 24 weeks, with at least two treatments occurring beyond the date when the initial CR was declared)</li><li>Intercurrent illness</li><li>Unacceptable adverse event(s)</li><li>Withdrawal of consent</li><li>General/specific changes in the patient's condition that render the patient unacceptable for further treatment</li></ul>",
"groupId": "FG001",
"numSubjects": "0"
}
],
"type": "COMPLETED"
},
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "18"
}
],
"type": "NOT COMPLETED"
}
],
"title": "Crossover Treatment"
}
],
"preAssignmentDetails": "96 patients were assessed for eligibility, and 18 were found to be ineligible.\nA total of 78 patients were enrolled and randomized.",
"recruitmentDetails": "The first patient was enrolled on February 12, 2018, and the last patient was enrolled on September 23, 2020."
}
}
},
{
"op": "add",
"path": "/annotationSection",
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"unpostedEvents": [
{
"date": "2022-12-09",
"type": "RESET"
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],
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},
{
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"date": "2021-02-02",
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"hasSap": true,
"label": "Study Protocol and Statistical Analysis Plan",
"size": 1531659,
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"review_question": "What source document explains this registry amendment, and does it change interpretation of the trial record?",
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