Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2026-04"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
"value": "2025-01-31"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2026-04-06"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2026-04-24"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2026-04-06"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2026-04-06"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2026-04-24",
"type": "ACTUAL"
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "<p>Clinical benefit ratio (CBR) is defined as the percentage of patients that achieve CR, PR, or stable disease for a minimum of four months.\nPatients will be evaluated for response by RECIST 1.1 and irRECIST.</p><p>Complete Response (CR)(RECIST1.1):\nAll target lesions disappear.\nAny pathological lymph nodes must have a reduction in short axis to <10 mm.</p><p>Partial Response (PR)(RECIST1.1):\nAt least a 30 % decrease in the sum of the longest diameters (LD) of target lesions, using the baseline sum as reference.</p><p>Stable Disease (SD)(RECIST1.1):\nNeither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking the smallest sum of diameters since treatment started as a reference irCR(irRECIST):Complete Resolution of non-nodal lesions and <10 mm short-axis for lymph nodes irPR(irRECIST): ≥30% decrease in tumor burden irSD(irRECIST): Does not meet criteria for irCR/irPR/irPD</p>"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "From C1D1 up to a maximum of 31 months or until death"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Safety Profile of Pembrolizumab Plus Fulvestrant"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"value": "The toxicity profile will report all grade 3 and 4 toxicities as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v4"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"value": "From C1D1 up to a maximum of 18 months or until death"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"value": "Progression Free Survival (PFS)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"value": "From C1D1 up to a maximum of 33 months or until death"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"value": "Durable Response Rate (DRR)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"value": "<p>Durable response rate is defined as the number of months that a stable disease, partial or complete response per RECIST 1.1 is observed.</p><p>Complete Response (CR): All target lesions disappear.\nAny pathological lymph nodes must have a reduction in short axis to <10 mm.</p><p>Partial Response (PR): At least a 30 % decrease in the sum of the longest diameters (LD) of target lesions, using the baseline sum as reference.</p><p>Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking the smallest sum of diameters since treatment started as a reference</p>"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
"value": "From C1D1 until death or up to a maximum of 31 months"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
"value": "From C1D1 up to a maximum of 44 months until death"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"moreInfoModule": {
"pointOfContact": {
"email": "amajumdar@hoosiercancer.org",
"phone": "3179212050",
"title": "Clinical Data Analyst",
"organization": "Hoosier Cancer Research Network"
},
"certainAgreement": {
"piSponsorEmployee": false,
"restrictiveAgreement": false
}
},
"adverseEventsModule": {
"timeFrame": "Adverse Events have been recorded from the time of consent until 30 days after treatment discontinuation of study drugs or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 10 months",
"reviewUnit": {
"resetReasons": [
"The Time Frame appears inconsistent with information provided here or in other parts of the record."
]
},
"description": "Adverse events were recorded from the time of consent for at least 90 days after treatment discontinuation, per Common Terminology Criteria for Adverse Events (CTCAE) v4.\nEvents were assessed at every visit at an interval of 21 days.",
"eventGroups": [
{
"id": "EG000",
"title": "Pembrolizumab, 200 mg + Fulvestrant, 500mg",
"description": "<p>Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 21 days.\nSites should make every effort to target infusion timing to be as close to 30 minutes as possible.\nHowever, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).</p><p>Fulvestrant 500 mg will be administered as two 5mL IM injections (one in each buttock).\nThe standard dosing is as follows: Loading doses will be given on Cycle 1 Day 1 and 15.\nThereafter, dosing will be every 4 weeks.</p>",
"otherNumAtRisk": 47,
"deathsNumAtRisk": 47,
"otherNumAffected": 46,
"seriousNumAtRisk": 47,
"deathsNumAffected": 25,
"seriousNumAffected": 12
}
],
"otherEvents": [
{
"term": "ABDOMINAL INFECTION",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "ABDOMINAL PAIN",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 15,
"numAffected": 9
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "ACUTE KIDNEY INJURY",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "AGITATION",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "ALANINE AMINOTRANSFERASE INCREASED",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 21,
"numAffected": 16
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "ALKALINE PHOSPHATASE INCREASED",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 35,
"numAffected": 17
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "ALLERGIC REACTION",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Immune system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "ALLERGIC RHINITIS",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 4,
"numAffected": 3
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "ALOPECIA",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "ANEMIA",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 54,
"numAffected": 21
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "ANOREXIA",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 6,
"numAffected": 4
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "ANXIETY",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 4,
"numAffected": 3
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "ARTHRALGIA",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 6,
"numAffected": 5
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "ARTHRITIS",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "ASPARTATE AMINOTRANSFERASE INCREASED",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 36,
"numAffected": 22
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "BACK PAIN",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 6,
"numAffected": 4
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "BLOATING",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "BLOOD BILIRUBIN INCREASED",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 6,
"numAffected": 4
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "BLURRED VISION",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Eye disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "BONE INFECTION",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "BONE PAIN",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 5,
"numAffected": 4
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "BREAST PAIN",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Reproductive system and breast disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "BRONCHOSPASM",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "BRUISING",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 4,
"numAffected": 3
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "BULLOUS DERMATITIS",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "CARDIAC TROPONIN I INCREASED",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "CHEST WALL PAIN",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "CHILLS",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 2,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "CONFUSION",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "CONSTIPATION",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 13,
"numAffected": 12
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "COUGH",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 9,
"numAffected": 6
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "CREATININE INCREASED",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 7,
"numAffected": 6
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "DEHYDRATION",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "DEPRESSION",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "DIARRHEA",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 25,
"numAffected": 14
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "DIZZINESS",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 4,
"numAffected": 4
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "DRY SKIN",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "DYSGEUSIA",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "DYSPEPSIA",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 3,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "DYSPHAGIA",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "DYSPNEA",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 16,
"numAffected": 10
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Ear and labyrinth disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "EAR PAIN",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Ear and labyrinth disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "EDEMA LIMBS",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 4,
"numAffected": 3
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "ERYTHEMA MULTIFORME",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "EYE DISORDERS - OTHER, SPECIFY",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Eye disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "FACIAL PAIN",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 5,
"numAffected": 2
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "FALL",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "FATIGUE",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 25,
"numAffected": 20
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "FEVER",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "FLANK PAIN",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 2,
"numAffected": 1
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "FLU LIKE SYMPTOMS",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 3,
"numAffected": 2
}
],
"organSystem": "General disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "FRACTURE",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "GASTROESOPHAGEAL REFLUX DISEASE",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
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"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "URINARY FREQUENCY",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "URINARY TRACT INFECTION",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 7,
"numAffected": 4
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "URINARY TRACT OBSTRUCTION",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "URINARY TRACT PAIN",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "URINARY URGENCY",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "URTICARIA",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "VAGINAL INFECTION",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "VENTRICULAR TACHYCARDIA",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "VOICE ALTERATION",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "VOMITING",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 10,
"numAffected": 6
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "WEIGHT GAIN",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 2,
"numAffected": 1
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "WEIGHT LOSS",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 6,
"numAffected": 6
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "WHITE BLOOD CELL DECREASED",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 19,
"numAffected": 11
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
}
],
"seriousEvents": [
{
"term": "ACUTE KIDNEY INJURY",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "ALANINE AMINOTRANSFERASE INCREASED",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "ASCITES",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "ASPARTATE AMINOTRANSFERASE INCREASED",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Investigations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "ATRIAL FIBRILLATION",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "COLITIS",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "CONSTIPATION",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "DYSPHAGIA",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "DYSPNEA",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "FALL",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "FRACTURE",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "HYPERCALCEMIA",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "INFECTIONS AND INFESTATIONS - OTHER, SPECIFY",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "PLEURAL EFFUSION",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 4,
"numAffected": 2
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "SEPSIS",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
},
{
"term": "URINARY TRACT INFECTION",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 47,
"numEvents": 2,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAEv5"
}
],
"frequencyThreshold": "0"
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"type": "PRIMARY",
"title": "Clinical Benefit Ratio (CBR)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "44",
"groupId": "OG000"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Pembrolizumab, 200 mg + Fulvestrant, 500mg",
"description": "<p>Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 21 days.\nSites should make every effort to target infusion timing to be as close to 30 minutes as possible.\nHowever, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).</p><p>Fulvestrant 500 mg will be administered as two 5mL IM injections (one in each buttock).\nThe standard dosing is as follows: Loading doses will be given on Cycle 1 Day 1 and 15.\nThereafter, dosing will be every 4 weeks.</p>"
}
],
"classes": [
{
"title": "RECIST 1.1",
"categories": [
{
"measurements": [
{
"value": "16",
"groupId": "OG000"
}
]
}
]
},
{
"title": "irRECIST",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "From C1D1 up to a maximum of 31 months or until death",
"description": "<p>Clinical benefit ratio (CBR) is defined as the percentage of patients that achieve CR, PR, or stable disease for a minimum of four months.\nPatients will be evaluated for response by RECIST 1.1 and irRECIST.</p><p>Complete Response (CR)(RECIST1.1):\nAll target lesions disappear.\nAny pathological lymph nodes must have a reduction in short axis to <10 mm.</p><p>Partial Response (PR)(RECIST1.1):\nAt least a 30 % decrease in the sum of the longest diameters (LD) of target lesions, using the baseline sum as reference.</p><p>Stable Disease (SD)(RECIST1.1):\nNeither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking the smallest sum of diameters since treatment started as a reference irCR(irRECIST):Complete Resolution of non-nodal lesions and <10 mm short-axis for lymph nodes irPR(irRECIST): ≥30% decrease in tumor burden irSD(irRECIST): Does not meet criteria for irCR/irPR/irPD</p>",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "Out of 47 enrolled subjects, 44 subjects received the study treatment and were deemed evaluable for efficacy.\nClinical Benefit Ratio has not been analyzed per irRECIST, therefore the count is kept 0.",
"measureCategoriesReviewUnit": {
"resetReasons": [
"One or more numbers in the table appear to be nonmeaningful placeholders that do not reflect data collected during the study."
]
}
},
{
"type": "SECONDARY",
"title": "Safety Profile of Pembrolizumab Plus Fulvestrant",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "47",
"groupId": "OG000"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Pembrolizumab, 200 mg + Fulvestrant, 500mg",
"description": "<p>Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 21 days.\nSites should make every effort to target infusion timing to be as close to 30 minutes as possible.\nHowever, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).</p><p>Fulvestrant 500 mg will be administered as two 5mL IM injections (one in each buttock).\nThe standard dosing is as follows: Loading doses will be given on Cycle 1 Day 1 and 15.\nThereafter, dosing will be every 4 weeks.</p>"
}
],
"classes": [
{
"title": "Number of patients had at least one adverse event of any grade",
"categories": [
{
"measurements": [
{
"value": "46",
"groupId": "OG000"
}
]
}
]
},
{
"title": "Number of patients had at least one grade 3 and greater adverse event",
"categories": [
{
"measurements": [
{
"value": "23",
"groupId": "OG000"
}
]
}
]
},
{
"title": "Number of patients had at least one grade 3 or greater Pembrolizumab related adverse event",
"categories": [
{
"measurements": [
{
"value": "8",
"groupId": "OG000"
}
]
}
]
},
{
"title": "Number of patients had at least one grade 3 or greater Fulvestrant related adverse event",
"categories": [
{
"measurements": [
{
"value": "2",
"groupId": "OG000"
}
]
}
]
},
{
"title": "Number of patients having serious adverse event",
"categories": [
{
"measurements": [
{
"value": "12",
"groupId": "OG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "From C1D1 up to a maximum of 18 months or until death",
"description": "The toxicity profile will report all grade 3 and 4 toxicities as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v4",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED"
},
{
"type": "SECONDARY",
"title": "Progression Free Survival (PFS)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "47",
"groupId": "OG000"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Pembrolizumab, 200 mg + Fulvestrant, 500mg",
"description": "<p>Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 21 days.\nSites should make every effort to target infusion timing to be as close to 30 minutes as possible.\nHowever, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).</p><p>Fulvestrant 500 mg will be administered as two 5mL IM injections (one in each buttock).\nThe standard dosing is as follows: Loading doses will be given on Cycle 1 Day 1 and 15.\nThereafter, dosing will be every 4 weeks.</p>"
}
],
"classes": [
{
"title": "RECIST 1.1",
"categories": [
{
"measurements": [
{
"value": "2.3",
"groupId": "OG000",
"lowerLimit": "0.2",
"upperLimit": "33.0"
}
]
}
]
},
{
"title": "irRECIST",
"categories": [
{
"measurements": [
{
"value": "4.1",
"groupId": "OG000",
"lowerLimit": "0.2",
"upperLimit": "33.0"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "From C1D1 up to a maximum of 33 months or until death",
"description": "Progression free survival is defined as the time from date of treatment start until the criteria for disease progression is met or death from any cause.\nPFS will be assessed by RECIST 1.1 and irRECIST",
"unitOfMeasure": "months",
"dispersionType": "Full Range",
"reportingStatus": "POSTED"
},
{
"type": "SECONDARY",
"title": "Durable Response Rate (DRR)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "44",
"groupId": "OG000"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Pembrolizumab, 200 mg + Fulvestrant, 500mg",
"description": "<p>Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 21 days.\nSites should make every effort to target infusion timing to be as close to 30 minutes as possible.\nHowever, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).</p><p>Fulvestrant 500 mg will be administered as two 5mL IM injections (one in each buttock).\nThe standard dosing is as follows: Loading doses will be given on Cycle 1 Day 1 and 15.\nThereafter, dosing will be every 4 weeks.</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "6.3",
"groupId": "OG000",
"lowerLimit": "2.3",
"upperLimit": "30.3"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "From C1D1 until death or up to a maximum of 31 months",
"description": "<p>Durable response rate is defined as the number of months that a stable disease, partial or complete response per RECIST 1.1 is observed.</p><p>Complete Response (CR): All target lesions disappear.\nAny pathological lymph nodes must have a reduction in short axis to <10 mm.</p><p>Partial Response (PR): At least a 30 % decrease in the sum of the longest diameters (LD) of target lesions, using the baseline sum as reference.</p><p>Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking the smallest sum of diameters since treatment started as a reference</p>",
"unitOfMeasure": "months",
"dispersionType": "Full Range",
"reportingStatus": "POSTED",
"populationDescription": "Out of 47 enrolled subjects, 44 subjects received the study treatment and were deemed evaluable for efficacy."
},
{
"type": "SECONDARY",
"title": "Overall Survival",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "47",
"groupId": "OG000"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Pembrolizumab, 200 mg + Fulvestrant, 500mg",
"description": "<p>Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 21 days.\nSites should make every effort to target infusion timing to be as close to 30 minutes as possible.\nHowever, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).</p><p>Fulvestrant 500 mg will be administered as two 5mL IM injections (one in each buttock).\nThe standard dosing is as follows: Loading doses will be given on Cycle 1 Day 1 and 15.\nThereafter, dosing will be every 4 weeks.</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "27.86",
"groupId": "OG000",
"lowerLimit": "1.68",
"upperLimit": "43.4"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "From C1D1 up to a maximum of 44 months until death",
"description": "Overall survival is defined as defined as the time from date of treatment start until death",
"unitOfMeasure": "months",
"dispersionType": "Full Range",
"reportingStatus": "POSTED"
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"title": "Pembrolizumab, 200 mg + Fulvestrant, 500mg",
"description": "<p>Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 21 days.\nSites should make every effort to target infusion timing to be as close to 30 minutes as possible.\nHowever, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).</p><p>Fulvestrant 500 mg will be administered as two 5mL IM injections (one in each buttock).\nThe standard dosing is as follows: Loading doses will be given on Cycle 1 Day 1 and 15.\nThereafter, dosing will be every 4 weeks.</p>"
}
],
"periods": [
{
"title": "Overall Study",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "47"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "9"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "38"
}
]
}
],
"dropWithdraws": [
{
"type": "Death",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "25"
}
]
},
{
"type": "Lost to Follow-up",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
}
]
},
{
"type": "Patient refused to follow up",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "4"
}
]
},
{
"type": "symptomatic deterioration",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
}
]
},
{
"type": "Patient did not start study treatment. Removed Per Dr Tandra and will receive SOC Eribulin.",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
}
]
},
{
"type": "Patient stated that she wanted her consent withdrawn.",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
}
]
},
{
"type": "Subjects are still on survival follow up.",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "5"
}
]
}
]
}
]
},
"baselineCharacteristicsModule": {
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "47",
"groupId": "BG000"
}
]
}
],
"groups": [
{
"id": "BG000",
"title": "Pembrolizumab, 200 mg + Fulvestrant, 500mg",
"description": "<p>Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 21 days.\nSites should make every effort to target infusion timing to be as close to 30 minutes as possible.\nHowever, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).</p><p>Fulvestrant 500 mg will be administered as two 5mL IM injections (one in each buttock).\nThe standard dosing is as follows: Loading doses will be given on Cycle 1 Day 1 and 15.\nThereafter, dosing will be every 4 weeks.</p>"
}
],
"measures": [
{
"title": "Age, Categorical",
"classes": [
{
"categories": [
{
"title": "<=18 years",
"measurements": [
{
"value": "0",
"groupId": "BG000"
}
]
},
{
"title": "Between 18 and 65 years",
"measurements": [
{
"value": "29",
"groupId": "BG000"
}
]
},
{
"title": ">=65 years",
"measurements": [
{
"value": "18",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Sex: Female, Male",
"classes": [
{
"categories": [
{
"title": "Female",
"measurements": [
{
"value": "46",
"groupId": "BG000"
}
]
},
{
"title": "Male",
"measurements": [
{
"value": "1",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Ethnicity (NIH/OMB)",
"classes": [
{
"categories": [
{
"title": "Hispanic or Latino",
"measurements": [
{
"value": "4",
"groupId": "BG000"
}
]
},
{
"title": "Not Hispanic or Latino",
"measurements": [
{
"value": "43",
"groupId": "BG000"
}
]
},
{
"title": "Unknown or Not Reported",
"measurements": [
{
"value": "0",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Race (NIH/OMB)",
"classes": [
{
"categories": [
{
"title": "American Indian or Alaska Native",
"measurements": [
{
"value": "0",
"groupId": "BG000"
}
]
},
{
"title": "Asian",
"measurements": [
{
"value": "0",
"groupId": "BG000"
}
]
},
{
"title": "Native Hawaiian or Other Pacific Islander",
"measurements": [
{
"value": "0",
"groupId": "BG000"
}
]
},
{
"title": "Black or African American",
"measurements": [
{
"value": "5",
"groupId": "BG000"
}
]
},
{
"title": "White",
"measurements": [
{
"value": "39",
"groupId": "BG000"
}
]
},
{
"title": "More than one race",
"measurements": [
{
"value": "0",
"groupId": "BG000"
}
]
},
{
"title": "Unknown or Not Reported",
"measurements": [
{
"value": "3",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "ECOG",
"classes": [
{
"categories": [
{
"title": "0",
"measurements": [
{
"value": "32",
"groupId": "BG000"
}
]
},
{
"title": "1",
"measurements": [
{
"value": "14",
"groupId": "BG000"
}
]
},
{
"title": "Not collected",
"measurements": [
{
"value": "1",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"description": "<p>ECOG Performance Status :</p><p>Grade 0: Fully active; no limitations on daily activities.\nGrade 1: Restricted in physically strenuous activity but ambulatory and able to perform light work.</p><p>Grade 2: Ambulatory and capable of all self-care; unable to work; up >50% of waking hours.</p><p>Grade 3: Capable of limited self-care; confined to bed/chair >50% of waking hours.</p><p>Grade 4: Completely disabled; totally confined to bed/chair.\nGrade 5: Dead.</p>",
"unitOfMeasure": "Participants"
}
]
}
}
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"date": "2026-04-23",
"type": "RESET"
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"unpostedResponsibleParty": "Nancy Chan, MD, Sponsor Investigator, Big Ten Cancer Research Consortium"
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"typeAbbrev": "Prot_SAP",
"uploadDate": "2026-03-27T11:26",
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