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NCT00099437

Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.

Version 15 to 16 · AstraZeneca

Patch inspector

Version 15 to 16

32 operations 8 path groups ctgov_internal_history
ClinicalTrials.gov
Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip the pipeline's suppression passes); the authoritative classification is the stored event record.
Plain-language summary

Manual review pending.

Rules fired
arms_or_interventions_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
    "signal": "milestone_realized",
    "category": "milestone_realized",
    "new_date": "2009-02",
    "new_type": "ACTUAL",
    "old_date": "2009-02",
    "old_type": "ESTIMATED",
    "severity": "low",
    "delta_days": 0,
    "date_struct": "primaryCompletionDateStruct"
  },
  {
    "path": "/protocolSection/statusModule/completionDateStruct/type",
    "signal": "milestone_realized",
    "category": "milestone_realized",
    "new_date": "2009-07",
    "new_type": "ACTUAL",
    "old_date": "2009-07",
    "old_type": "ESTIMATED",
    "severity": "low",
    "delta_days": 0,
    "date_struct": "completionDateStruct"
  },
  {
    "paths": [
      "/protocolSection/outcomesModule/primaryOutcomes/0/description",
      "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
      "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
      "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
      "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
      "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
      "/protocolSection/outcomesModule/secondaryOutcomes/1",
      "/protocolSection/outcomesModule/secondaryOutcomes/2",
      "/protocolSection/outcomesModule/secondaryOutcomes/3",
      "/protocolSection/outcomesModule/secondaryOutcomes/4",
      "/protocolSection/outcomesModule/secondaryOutcomes/5"
    ],
    "signal": "results_reconciliation_outcome_suppression",
    "category": "results_reconciliation",
    "severity": "low"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:00:00+00
Raw hash
ebb137d1da404cda7cb3959f305f3bce170511ca26972d31fab32459f4611838
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 3 ops
replace /protocolSection/outcomesModule/primaryOutcomes/0/measure
Triage: Critical
Primary Outcome Change Operation 13
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Time To Progression (TTP)
After
Time to Progression (TTP)
replace /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
Triage: Critical
Primary Outcome Change Operation 14
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
assessed after 632 progression events
After
RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
add /protocolSection/outcomesModule/primaryOutcomes/0/description
Triage: Critical
Primary Outcome Change Operation 15
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
After
Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 1 ops
replace /protocolSection/armsInterventionsModule/interventions/0/description
Triage: High
Arm Intervention Change Operation 12
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
intramuscular injection 250 mg & 500 mg
After
intramuscular injection
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 8 ops
replace /protocolSection/outcomesModule/secondaryOutcomes/0/measure
Triage: High
Secondary Outcome Change Operation 16
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Objective Response, Clinical Benefit Rate, Duration of Response, Duration of Clinical Benefit, Overall survival, Quality of Life
After
Objective Response Rate (ORR)
replace /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame
Triage: High
Secondary Outcome Change Operation 17
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
assessed after 632 progression events
After
RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
add /protocolSection/outcomesModule/secondaryOutcomes/0/description
Triage: High
Secondary Outcome Change Operation 18
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
Using the RECIST scan data, an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR) which is subsequently confirmed as per RECIST.
ORR is defined as the percentage of patients with OR.
add /protocolSection/outcomesModule/secondaryOutcomes/1
Triage: High
Secondary Outcome Change Operation 19
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Clinical Benefit Rate (CBR)",
  "timeFrame": "Clinical Benefit from the sequence of RECIST scan data for study duration (48 months) . RECIST (Response Evaluation Criteria in Solid Tumours) scans were performed every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)",
  "description": "A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD (stable disease) >=24 weeks.\nThe Clinical Benefit Rate is the percentage of patients with CB."
}
add /protocolSection/outcomesModule/secondaryOutcomes/2
Triage: High
Secondary Outcome Change Operation 20
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Duration of Response (DoR)",
  "timeFrame": "RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)",
  "description": "Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR) or confirmed partial response (PR)"
}
add /protocolSection/outcomesModule/secondaryOutcomes/3
Triage: High
Secondary Outcome Change Operation 21
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Duration of Clinical Benefit (DoCB)",
  "timeFrame": "RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)",
  "description": "Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) >=24 weeks"
}
add /protocolSection/outcomesModule/secondaryOutcomes/4
Triage: High
Secondary Outcome Change Operation 22
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Overall Survival (OS)",
  "timeFrame": "Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months)",
  "description": "Median time (in months) from randomisation until death (from any cause)"
}
add /protocolSection/outcomesModule/secondaryOutcomes/5
Triage: High
Secondary Outcome Change Operation 23
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Time to Deterioration in Trial Outcome Index (TOI)",
  "timeFrame": "TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months)",
  "description": "Median time (in months) from randomisation until deterioration in TOI (defined as the first visit response of 'worsened') using the Kaplan-Meier method.\nTrial Outcome Index (TOI) is derived from the FACT-B questionnaire.\nData were collected from a subgroup of patients."
}
Timeline Start, primary completion, and completion date movement. Triage: Medium 2 ops
replace /protocolSection/statusModule/primaryCompletionDateStruct/type
Triage: Medium
Timeline Shift Operation 4
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
ESTIMATED
After
ACTUAL
replace /protocolSection/statusModule/completionDateStruct/type
Triage: Medium
Timeline Shift Operation 5
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
ESTIMATED
After
ACTUAL
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 7 ops
replace /protocolSection/contactsLocationsModule/locations/25/state
Triage: Uncategorized
Uncategorized Operation 24
Before
S�O Paulo
After
S�o Paulo
replace /protocolSection/contactsLocationsModule/locations/31/state
Triage: Uncategorized
Uncategorized Operation 25
Before
PRAHA 5
After
Praha 5
replace /protocolSection/contactsLocationsModule/locations/39/state
Triage: Uncategorized
Uncategorized Operation 26
Before
ANDH PRAD
After
Andh Prad
replace /protocolSection/contactsLocationsModule/locations/41/state
Triage: Uncategorized
Uncategorized Operation 27
Before
KOLKATA
After
Kolkata
replace /protocolSection/contactsLocationsModule/locations/42/state
Triage: Uncategorized
Uncategorized Operation 28
Before
MADH PRAD
After
Madh Prad
replace /protocolSection/contactsLocationsModule/locations/43/state
Triage: Uncategorized
Uncategorized Operation 29
Before
NEW Dehli
After
New Dehli
replace /protocolSection/contactsLocationsModule/locations/52/state
Triage: Uncategorized
Uncategorized Operation 30
Before
PRATO
After
Prato
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 9 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2010-02
After
2010-05
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 6
Before
2010-02-02
After
2010-05-12
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 7
Before
2010-02-03
After
2010-06-15
add /protocolSection/statusModule/resultsFirstSubmitDate
Triage: Uncategorized
Uncategorized Operation 8
After
2010-02-23
add /protocolSection/statusModule/resultsFirstSubmitQcDate
Triage: Uncategorized
Uncategorized Operation 9
After
2010-05-12
add /protocolSection/statusModule/resultsFirstPostDateStruct
Triage: Uncategorized
Uncategorized Operation 10
After
{
  "date": "2010-06-15",
  "type": "ESTIMATED"
}
replace /protocolSection/descriptionModule/briefSummary
Triage: Uncategorized
Uncategorized Operation 11
Before
The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with estrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment.
After
The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment.
replace /hasResults
Triage: Uncategorized
Uncategorized Operation 31
Before
false
After
true
add /resultsSection
Triage: Uncategorized
Uncategorized Operation 32
After
{
  "moreInfoModule": {
    "pointOfContact": {
      "email": "aztrial_results_posting@astrazeneca.com",
      "title": "Gerard Lynch",
      "organization": "AstraZeneca"
    },
    "certainAgreement": {
      "otherDetails": "The only disclosure restriction on the PI is that they cannot publish any information to do with the trial without written consent from Quintiles.",
      "restrictionType": "OTHER",
      "piSponsorEmployee": false,
      "restrictiveAgreement": true
    }
  },
  "adverseEventsModule": {
    "description": "1 participant was randomised to fulvestrant 500 mg but did not recieve any treatment",
    "eventGroups": [
      {
        "id": "EG000",
        "title": "Fulvestrant 250 mg",
        "description": "Fulvestrant 250 mg Intramuscular Injection every 28 days",
        "otherNumAtRisk": 374,
        "otherNumAffected": 235,
        "seriousNumAtRisk": 374,
        "seriousNumAffected": 25
      },
      {
        "id": "EG001",
        "title": "Fulvestrant 500 mg",
        "description": "Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14",
        "otherNumAtRisk": 361,
        "otherNumAffected": 241,
        "seriousNumAtRisk": 361,
        "seriousNumAffected": 29
      }
    ],
    "otherEvents": [
      {
        "term": "Nausea",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 51
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 35
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Vomiting",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 20
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 21
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Injection Site Pain",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 34
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 42
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Fatigue",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 24
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 27
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Asthenia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 23
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 21
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Anorexia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 14
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 22
          }
        ],
        "organSystem": "Metabolism and nutrition disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Back Pain",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 40
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 26
          }
        ],
        "organSystem": "Musculoskeletal and connective tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Bone Pain",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 28
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 34
          }
        ],
        "organSystem": "Musculoskeletal and connective tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Arthralgia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 29
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 29
          }
        ],
        "organSystem": "Musculoskeletal and connective tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Pain In Extremity",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 26
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 25
          }
        ],
        "organSystem": "Musculoskeletal and connective tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Musculoskeletal Pain",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 12
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 20
          }
        ],
        "organSystem": "Musculoskeletal and connective tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Headache",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 25
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 28
          }
        ],
        "organSystem": "Nervous system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Cough",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 20
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 19
          }
        ],
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Hot Flush",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 22
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 24
          }
        ],
        "organSystem": "Vascular disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      }
    ],
    "seriousEvents": [
      {
        "term": "Anaemia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 1
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Neutropenia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 1
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Thrombocytopenia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 1
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Febrile Neutropenia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 0
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Cardiopulmonary Failure",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 1
          }
        ],
        "organSystem": "Cardiac disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Acute Myocardial Infarction",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 0
          }
        ],
        "organSystem": "Cardiac disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Myocardial Ischaemia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 0
          }
        ],
        "organSystem": "Cardiac disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Vomiting",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 3
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Abdominal Pain",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 1
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Constipation",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 1
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Duodenal Ulcer Perforation",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 1
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Peritonitis",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 1
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Gastrointestinal Haemorrhage",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
            "numAffected": 0
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA 11.1"
      },
      {
        "term": "Adverse Drug Reaction",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 374,
            "numAffected": 0
          },
          {
            "groupId": "EG001",
            "numAtRisk": 361,
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            "categories": [
              {
                "measurements": [
                  {
                    "value": "14.6",
                    "groupId": "OG000"
                  },
                  {
                    "value": "13.8",
                    "groupId": "OG001"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "NUMBER",
        "timeFrame": "RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)",
        "description": "Using the RECIST scan data, an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR) which is subsequently confirmed as per RECIST.\nORR is defined as the percentage of patients with OR.",
        "unitOfMeasure": "Percentage of patients",
        "reportingStatus": "POSTED",
        "populationDescription": "All patients with measurable disease at baseline."
      },
      {
        "type": "SECONDARY",
        "title": "Clinical Benefit Rate (CBR)",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "374",
                "groupId": "OG000"
              },
              {
                "value": "362",
                "groupId": "OG001"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Fulvestrant 250 mg",
            "description": "Fulvestrant 250 mg Intramuscular Injection every 28 days"
          },
          {
            "id": "OG001",
            "title": "Fulvestrant 500 mg",
            "description": "Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "39.6",
                    "groupId": "OG000"
                  },
                  {
                    "value": "45.6",
                    "groupId": "OG001"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "NUMBER",
        "timeFrame": "Clinical Benefit from the sequence of RECIST scan data for study duration (48 months) . RECIST (Response Evaluation Criteria in Solid Tumours) scans were performed every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)",
        "description": "A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD (stable disease) >=24 weeks.\nThe Clinical Benefit Rate is the percentage of patients with CB.",
        "unitOfMeasure": "Percentage of patients",
        "reportingStatus": "POSTED"
      },
      {
        "type": "SECONDARY",
        "title": "Duration of Response (DoR)",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "38",
                "groupId": "OG000"
              },
              {
                "value": "33",
                "groupId": "OG001"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Fulvestrant 250 mg",
            "description": "Fulvestrant 250 mg Intramuscular Injection every 28 days"
          },
          {
            "id": "OG001",
            "title": "Fulvestrant 500 mg",
            "description": "Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "16.4",
                    "groupId": "OG000",
                    "lowerLimit": "3.7",
                    "upperLimit": "44.6"
                  },
                  {
                    "value": "19.4",
                    "groupId": "OG001",
                    "lowerLimit": "5.7",
                    "upperLimit": "44.5"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEDIAN",
        "timeFrame": "RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)",
        "description": "Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR) or confirmed partial response (PR)",
        "unitOfMeasure": "Time (in months)",
        "dispersionType": "Full Range",
        "reportingStatus": "POSTED"
      },
      {
        "type": "SECONDARY",
        "title": "Duration of Clinical Benefit (DoCB)",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "148",
                "groupId": "OG000"
              },
              {
                "value": "165",
                "groupId": "OG001"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Fulvestrant 250 mg",
            "description": "Fulvestrant 250 mg Intramuscular Injection every 28 days"
          },
          {
            "id": "OG001",
            "title": "Fulvestrant 500 mg",
            "description": "Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "13.9",
                    "groupId": "OG000",
                    "lowerLimit": "3.7",
                    "upperLimit": "44.6"
                  },
                  {
                    "value": "16.6",
                    "groupId": "OG001",
                    "lowerLimit": "2.5",
                    "upperLimit": "44.5"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEDIAN",
        "timeFrame": "RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)",
        "description": "Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) >=24 weeks",
        "unitOfMeasure": "Time (in months)",
        "dispersionType": "Full Range",
        "reportingStatus": "POSTED"
      },
      {
        "type": "SECONDARY",
        "title": "Overall Survival (OS)",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "374",
                "groupId": "OG000"
              },
              {
                "value": "362",
                "groupId": "OG001"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "Fulvestrant 250 mg",
            "description": "Fulvestrant 250 mg Intramuscular Injection every 28 days"
          },
          {
            "id": "OG001",
            "title": "Fulvestrant 500 mg",
            "description": "Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14"
          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "22.8",
                    "groupId": "OG000",
                    "lowerLimit": "0.2",
                    "upperLimit": "44.6"
                  },
                  {
                    "value": "25.1",
                    "groupId": "OG001",
                    "lowerLimit": "0.1",
                    "upperLimit": "46.3"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEDIAN",
        "timeFrame": "Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months)",
        "description": "Median time (in months) from randomisation until death (from any cause)",
        "unitOfMeasure": "Time (in months)",
        "dispersionType": "Full Range",
        "reportingStatus": "POSTED",
        "populationDescription": "All patients with measurable disease at baseline."
      },
      {
        "type": "SECONDARY",
        "title": "Time to Deterioration in Trial Outcome Index (TOI)",
        "timeFrame": "TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months)",
        "description": "Median time (in months) from randomisation until deterioration in TOI (defined as the first visit response of 'worsened') using the Kaplan-Meier method.\nTrial Outcome Index (TOI) is derived from the FACT-B questionnaire.\nData were collected from a subgroup of patients.",
        "reportingStatus": "NOT_POSTED"
      }
    ]
  },
  "participantFlowModule": {
    "groups": [
      {
        "id": "FG000",
        "title": "Fulvestrant 250 mg",
        "description": "Fulvestrant 250 mg Intramuscular Injection every 28 days"
      },
      {
        "id": "FG001",
        "title": "Fulvestrant 500 mg",
        "description": "Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14"
      }
    ],
    "periods": [
      {
        "title": "Overall Study",
        "milestones": [
          {
            "type": "STARTED",
            "achievements": [
              {
                "comment": "randomised patients",
                "groupId": "FG000",
                "numSubjects": "374"
              },
              {
                "comment": "randomised patients",
                "groupId": "FG001",
                "numSubjects": "362"
              }
            ]
          },
          {
            "type": "COMPLETED",
            "achievements": [
              {
                "comment": "ongoing study treatment at data cut-off",
                "groupId": "FG000",
                "numSubjects": "31"
              },
              {
                "comment": "ongoing study treatment at data cut-off",
                "groupId": "FG001",
                "numSubjects": "41"
              }
            ]
          },
          {
            "type": "NOT COMPLETED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "343"
              },
              {
                "groupId": "FG001",
                "numSubjects": "321"
              }
            ]
          }
        ],
        "dropWithdraws": [
          {
            "type": "Protocol Violation",
            "reasons": [
              {
                "groupId": "FG000",
                "numSubjects": "4"
              },
              {
                "groupId": "FG001",
                "numSubjects": "4"
              }
            ]
          },
          {
            "type": "Adverse Event",
            "reasons": [
              {
                "groupId": "FG000",
                "numSubjects": "6"
              },
              {
                "groupId": "FG001",
                "numSubjects": "8"
              }
            ]
          },
          {
            "type": "Lack of Efficacy",
            "reasons": [
              {
                "groupId": "FG000",
                "numSubjects": "278"
              },
              {
                "groupId": "FG001",
                "numSubjects": "258"
              }
            ]
          },
          {
            "type": "Withdrawal by Subject",
            "reasons": [
              {
                "groupId": "FG000",
                "numSubjects": "16"
              },
              {
                "groupId": "FG001",
                "numSubjects": "18"
              }
            ]
          },
          {
            "type": "Lost to Follow-up",
            "reasons": [
              {
                "groupId": "FG000",
                "numSubjects": "1"
              },
              {
                "groupId": "FG001",
                "numSubjects": "3"
              }
            ]
          },
          {
            "type": "Death",
            "reasons": [
              {
                "groupId": "FG000",
                "numSubjects": "13"
              },
              {
                "groupId": "FG001",
                "numSubjects": "8"
              }
            ]
          },
          {
            "type": "protocol non-compliance",
            "reasons": [
              {
                "groupId": "FG000",
                "numSubjects": "2"
              },
              {
                "groupId": "FG001",
                "numSubjects": "2"
              }
            ]
          },
          {
            "type": "Other reasons eg. radiation treatment",
            "reasons": [
              {
                "groupId": "FG000",
                "numSubjects": "23"
              },
              {
                "groupId": "FG001",
                "numSubjects": "20"
              }
            ]
          }
        ]
      }
    ]
  },
  "baselineCharacteristicsModule": {
    "denoms": [
      {
        "units": "Participants",
        "counts": [
          {
            "value": "374",
            "groupId": "BG000"
          },
          {
            "value": "362",
            "groupId": "BG001"
          },
          {
            "value": "736",
            "groupId": "BG002"
          }
        ]
      }
    ],
    "groups": [
      {
        "id": "BG000",
        "title": "Fulvestrant 250 mg",
        "description": "Fulvestrant 250 mg Intramuscular Injection every 28 days"
      },
      {
        "id": "BG001",
        "title": "Fulvestrant 500 mg",
        "description": "Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14"
      },
      {
        "id": "BG002",
        "title": "Total",
        "description": "Total of all reporting groups"
      }
    ],
    "measures": [
      {
        "title": "Age Continuous",
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "60.8",
                    "spread": "11.94",
                    "groupId": "BG000"
                  },
                  {
                    "value": "61.0",
                    "spread": "11.47",
                    "groupId": "BG001"
                  },
                  {
                    "value": "60.9",
                    "spread": "11.71",
                    "groupId": "BG002"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEAN",
        "unitOfMeasure": "Years",
        "dispersionType": "STANDARD_DEVIATION"
      },
      {
        "title": "Sex: Female, Male",
        "classes": [
          {
            "categories": [
              {
                "title": "Female",
                "measurements": [
                  {
                    "value": "374",
                    "groupId": "BG000"
                  },
                  {
                    "value": "362",
                    "groupId": "BG001"
                  },
                  {
                    "value": "736",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "Male",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      }
    ]
  }
}
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 1 ops
replace /protocolSection/identificationModule/briefTitle
Triage: Uncategorized
Uncategorized Operation 1
Before
Comparison of Fulvestrant (FASLODEX™) 250 mg and 500mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.
After
Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.
Status and stopping reason Recruitment status, termination, suspension, withdrawal, or why-stopped text. Triage: Uncategorized 1 ops
replace /protocolSection/statusModule/overallStatus
Triage: Uncategorized
Uncategorized Operation 3
Before
ACTIVE_NOT_RECRUITING
After
COMPLETED
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/briefTitle",
    "value": "Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy."
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2010-05"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "COMPLETED"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2010-05-12"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2010-06-15"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstSubmitDate",
    "value": "2010-02-23"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
    "value": "2010-05-12"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
    "value": {
      "date": "2010-06-15",
      "type": "ESTIMATED"
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/descriptionModule/briefSummary",
    "value": "The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment."
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/description",
    "value": "intramuscular injection"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
    "value": "Time to Progression (TTP)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "value": "Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression)."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
    "value": "Objective Response Rate (ORR)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "value": "RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
    "value": "Using the RECIST scan data, an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR) which is subsequently confirmed as per RECIST.\nORR is defined as the percentage of patients with OR."
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1",
    "value": {
      "measure": "Clinical Benefit Rate (CBR)",
      "timeFrame": "Clinical Benefit from the sequence of RECIST scan data for study duration (48 months) . RECIST (Response Evaluation Criteria in Solid Tumours) scans were performed every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)",
      "description": "A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD (stable disease) >=24 weeks.\nThe Clinical Benefit Rate is the percentage of patients with CB."
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2",
    "value": {
      "measure": "Duration of Response (DoR)",
      "timeFrame": "RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)",
      "description": "Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR) or confirmed partial response (PR)"
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3",
    "value": {
      "measure": "Duration of Clinical Benefit (DoCB)",
      "timeFrame": "RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)",
      "description": "Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) >=24 weeks"
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4",
    "value": {
      "measure": "Overall Survival (OS)",
      "timeFrame": "Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months)",
      "description": "Median time (in months) from randomisation until death (from any cause)"
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/5",
    "value": {
      "measure": "Time to Deterioration in Trial Outcome Index (TOI)",
      "timeFrame": "TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months)",
      "description": "Median time (in months) from randomisation until deterioration in TOI (defined as the first visit response of 'worsened') using the Kaplan-Meier method.\nTrial Outcome Index (TOI) is derived from the FACT-B questionnaire.\nData were collected from a subgroup of patients."
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/25/state",
    "value": "S�o Paulo"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/31/state",
    "value": "Praha 5"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/39/state",
    "value": "Andh Prad"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/41/state",
    "value": "Kolkata"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/42/state",
    "value": "Madh Prad"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/43/state",
    "value": "New Dehli"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/52/state",
    "value": "Prato"
  },
  {
    "op": "replace",
    "path": "/hasResults",
    "value": true
  },
  {
    "op": "add",
    "path": "/resultsSection",
    "value": {
      "moreInfoModule": {
        "pointOfContact": {
          "email": "aztrial_results_posting@astrazeneca.com",
          "title": "Gerard Lynch",
          "organization": "AstraZeneca"
        },
        "certainAgreement": {
          "otherDetails": "The only disclosure restriction on the PI is that they cannot publish any information to do with the trial without written consent from Quintiles.",
          "restrictionType": "OTHER",
          "piSponsorEmployee": false,
          "restrictiveAgreement": true
        }
      },
      "adverseEventsModule": {
        "description": "1 participant was randomised to fulvestrant 500 mg but did not recieve any treatment",
        "eventGroups": [
          {
            "id": "EG000",
            "title": "Fulvestrant 250 mg",
            "description": "Fulvestrant 250 mg Intramuscular Injection every 28 days",
            "otherNumAtRisk": 374,
            "otherNumAffected": 235,
            "seriousNumAtRisk": 374,
            "seriousNumAffected": 25
          },
          {
            "id": "EG001",
            "title": "Fulvestrant 500 mg",
            "description": "Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14",
            "otherNumAtRisk": 361,
            "otherNumAffected": 241,
            "seriousNumAtRisk": 361,
            "seriousNumAffected": 29
          }
        ],
        "otherEvents": [
          {
            "term": "Nausea",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 374,
                "numAffected": 51
              },
              {
                "groupId": "EG001",
                "numAtRisk": 361,
                "numAffected": 35
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 11.1"
          },
          {
            "term": "Vomiting",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 374,
                "numAffected": 20
              },
              {
                "groupId": "EG001",
                "numAtRisk": 361,
                "numAffected": 21
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 11.1"
          },
          {
            "term": "Injection Site Pain",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 374,
                "numAffected": 34
              },
              {
                "groupId": "EG001",
                "numAtRisk": 361,
                "numAffected": 42
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 11.1"
          },
          {
            "term": "Fatigue",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 374,
                "numAffected": 24
              },
              {
                "groupId": "EG001",
                "numAtRisk": 361,
                "numAffected": 27
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 11.1"
          },
          {
            "term": "Asthenia",
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              {
                "groupId": "EG000",
                "numAtRisk": 374,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 361,
                "numAffected": 0
              }
            ],
            "organSystem": "Nervous system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 11.1"
          },
          {
            "term": "Completed Suicide",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 374,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 361,
                "numAffected": 0
              }
            ],
            "organSystem": "Psychiatric disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 11.1"
          },
          {
            "term": "Renal Failure Acute",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 374,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 361,
                "numAffected": 0
              }
            ],
            "organSystem": "Renal and urinary disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 11.1"
          },
          {
            "term": "Dyspnoea",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 374,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 361,
                "numAffected": 2
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 11.1"
          },
          {
            "term": "Interstitial Lung Disease",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 374,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 361,
                "numAffected": 1
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 11.1"
          },
          {
            "term": "Pleural Effusion",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 374,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 361,
                "numAffected": 1
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 11.1"
          },
          {
            "term": "Pulmonary Embolism",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 374,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 361,
                "numAffected": 1
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 11.1"
          },
          {
            "term": "Aspiration",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 374,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 361,
                "numAffected": 0
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 11.1"
          },
          {
            "term": "Hydrothorax",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 374,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 361,
                "numAffected": 0
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 11.1"
          },
          {
            "term": "Pleurisy",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 374,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 361,
                "numAffected": 0
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 11.1"
          },
          {
            "term": "Pneumothorax",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 374,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 361,
                "numAffected": 0
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 11.1"
          },
          {
            "term": "Respiratory Failure",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 374,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 361,
                "numAffected": 0
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 11.1"
          },
          {
            "term": "Hypertension",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 374,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 361,
                "numAffected": 1
              }
            ],
            "organSystem": "Vascular disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 11.1"
          },
          {
            "term": "Venous Thrombosis Limb",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 374,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 361,
                "numAffected": 1
              }
            ],
            "organSystem": "Vascular disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 11.1"
          },
          {
            "term": "Arterial Thrombosis Limb",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 374,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 361,
                "numAffected": 0
              }
            ],
            "organSystem": "Vascular disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 11.1"
          },
          {
            "term": "Deep Vein Thrombosis",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 374,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 361,
                "numAffected": 0
              }
            ],
            "organSystem": "Vascular disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 11.1"
          },
          {
            "term": "Iliac Artery Embolism",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 374,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 361,
                "numAffected": 0
              }
            ],
            "organSystem": "Vascular disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 11.1"
          },
          {
            "term": "Venous Thrombosis",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 374,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 361,
                "numAffected": 0
              }
            ],
            "organSystem": "Vascular disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA 11.1"
          }
        ],
        "frequencyThreshold": "5"
      },
      "outcomeMeasuresModule": {
        "outcomeMeasures": [
          {
            "type": "PRIMARY",
            "title": "Time to Progression (TTP)",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "374",
                    "groupId": "OG000"
                  },
                  {
                    "value": "362",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Fulvestrant 250 mg",
                "description": "Fulvestrant 250 mg Intramuscular Injection every 28 days"
              },
              {
                "id": "OG001",
                "title": "Fulvestrant 500 mg",
                "description": "Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "5.5",
                        "groupId": "OG000",
                        "lowerLimit": "0",
                        "upperLimit": "44.6"
                      },
                      {
                        "value": "6.5",
                        "groupId": "OG001",
                        "lowerLimit": "0",
                        "upperLimit": "44.5"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEDIAN",
            "timeFrame": "RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)",
            "description": "Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).",
            "unitOfMeasure": "months",
            "dispersionType": "Full Range",
            "reportingStatus": "POSTED"
          },
          {
            "type": "SECONDARY",
            "title": "Objective Response Rate (ORR)",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "261",
                    "groupId": "OG000"
                  },
                  {
                    "value": "240",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Fulvestrant 250 mg",
                "description": "Fulvestrant 250 mg Intramuscular Injection every 28 days"
              },
              {
                "id": "OG001",
                "title": "Fulvestrant 500 mg",
                "description": "Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "14.6",
                        "groupId": "OG000"
                      },
                      {
                        "value": "13.8",
                        "groupId": "OG001"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "NUMBER",
            "timeFrame": "RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)",
            "description": "Using the RECIST scan data, an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR) which is subsequently confirmed as per RECIST.\nORR is defined as the percentage of patients with OR.",
            "unitOfMeasure": "Percentage of patients",
            "reportingStatus": "POSTED",
            "populationDescription": "All patients with measurable disease at baseline."
          },
          {
            "type": "SECONDARY",
            "title": "Clinical Benefit Rate (CBR)",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "374",
                    "groupId": "OG000"
                  },
                  {
                    "value": "362",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Fulvestrant 250 mg",
                "description": "Fulvestrant 250 mg Intramuscular Injection every 28 days"
              },
              {
                "id": "OG001",
                "title": "Fulvestrant 500 mg",
                "description": "Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "39.6",
                        "groupId": "OG000"
                      },
                      {
                        "value": "45.6",
                        "groupId": "OG001"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "NUMBER",
            "timeFrame": "Clinical Benefit from the sequence of RECIST scan data for study duration (48 months) . RECIST (Response Evaluation Criteria in Solid Tumours) scans were performed every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)",
            "description": "A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD (stable disease) >=24 weeks.\nThe Clinical Benefit Rate is the percentage of patients with CB.",
            "unitOfMeasure": "Percentage of patients",
            "reportingStatus": "POSTED"
          },
          {
            "type": "SECONDARY",
            "title": "Duration of Response (DoR)",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "38",
                    "groupId": "OG000"
                  },
                  {
                    "value": "33",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Fulvestrant 250 mg",
                "description": "Fulvestrant 250 mg Intramuscular Injection every 28 days"
              },
              {
                "id": "OG001",
                "title": "Fulvestrant 500 mg",
                "description": "Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "16.4",
                        "groupId": "OG000",
                        "lowerLimit": "3.7",
                        "upperLimit": "44.6"
                      },
                      {
                        "value": "19.4",
                        "groupId": "OG001",
                        "lowerLimit": "5.7",
                        "upperLimit": "44.5"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEDIAN",
            "timeFrame": "RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)",
            "description": "Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR) or confirmed partial response (PR)",
            "unitOfMeasure": "Time (in months)",
            "dispersionType": "Full Range",
            "reportingStatus": "POSTED"
          },
          {
            "type": "SECONDARY",
            "title": "Duration of Clinical Benefit (DoCB)",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "148",
                    "groupId": "OG000"
                  },
                  {
                    "value": "165",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Fulvestrant 250 mg",
                "description": "Fulvestrant 250 mg Intramuscular Injection every 28 days"
              },
              {
                "id": "OG001",
                "title": "Fulvestrant 500 mg",
                "description": "Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "13.9",
                        "groupId": "OG000",
                        "lowerLimit": "3.7",
                        "upperLimit": "44.6"
                      },
                      {
                        "value": "16.6",
                        "groupId": "OG001",
                        "lowerLimit": "2.5",
                        "upperLimit": "44.5"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEDIAN",
            "timeFrame": "RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)",
            "description": "Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) >=24 weeks",
            "unitOfMeasure": "Time (in months)",
            "dispersionType": "Full Range",
            "reportingStatus": "POSTED"
          },
          {
            "type": "SECONDARY",
            "title": "Overall Survival (OS)",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "374",
                    "groupId": "OG000"
                  },
                  {
                    "value": "362",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Fulvestrant 250 mg",
                "description": "Fulvestrant 250 mg Intramuscular Injection every 28 days"
              },
              {
                "id": "OG001",
                "title": "Fulvestrant 500 mg",
                "description": "Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "22.8",
                        "groupId": "OG000",
                        "lowerLimit": "0.2",
                        "upperLimit": "44.6"
                      },
                      {
                        "value": "25.1",
                        "groupId": "OG001",
                        "lowerLimit": "0.1",
                        "upperLimit": "46.3"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEDIAN",
            "timeFrame": "Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months)",
            "description": "Median time (in months) from randomisation until death (from any cause)",
            "unitOfMeasure": "Time (in months)",
            "dispersionType": "Full Range",
            "reportingStatus": "POSTED",
            "populationDescription": "All patients with measurable disease at baseline."
          },
          {
            "type": "SECONDARY",
            "title": "Time to Deterioration in Trial Outcome Index (TOI)",
            "timeFrame": "TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months)",
            "description": "Median time (in months) from randomisation until deterioration in TOI (defined as the first visit response of 'worsened') using the Kaplan-Meier method.\nTrial Outcome Index (TOI) is derived from the FACT-B questionnaire.\nData were collected from a subgroup of patients.",
            "reportingStatus": "NOT_POSTED"
          }
        ]
      },
      "participantFlowModule": {
        "groups": [
          {
            "id": "FG000",
            "title": "Fulvestrant 250 mg",
            "description": "Fulvestrant 250 mg Intramuscular Injection every 28 days"
          },
          {
            "id": "FG001",
            "title": "Fulvestrant 500 mg",
            "description": "Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14"
          }
        ],
        "periods": [
          {
            "title": "Overall Study",
            "milestones": [
              {
                "type": "STARTED",
                "achievements": [
                  {
                    "comment": "randomised patients",
                    "groupId": "FG000",
                    "numSubjects": "374"
                  },
                  {
                    "comment": "randomised patients",
                    "groupId": "FG001",
                    "numSubjects": "362"
                  }
                ]
              },
              {
                "type": "COMPLETED",
                "achievements": [
                  {
                    "comment": "ongoing study treatment at data cut-off",
                    "groupId": "FG000",
                    "numSubjects": "31"
                  },
                  {
                    "comment": "ongoing study treatment at data cut-off",
                    "groupId": "FG001",
                    "numSubjects": "41"
                  }
                ]
              },
              {
                "type": "NOT COMPLETED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "343"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "321"
                  }
                ]
              }
            ],
            "dropWithdraws": [
              {
                "type": "Protocol Violation",
                "reasons": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "4"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "4"
                  }
                ]
              },
              {
                "type": "Adverse Event",
                "reasons": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "6"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "8"
                  }
                ]
              },
              {
                "type": "Lack of Efficacy",
                "reasons": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "278"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "258"
                  }
                ]
              },
              {
                "type": "Withdrawal by Subject",
                "reasons": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "16"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "18"
                  }
                ]
              },
              {
                "type": "Lost to Follow-up",
                "reasons": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "1"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "3"
                  }
                ]
              },
              {
                "type": "Death",
                "reasons": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "13"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "8"
                  }
                ]
              },
              {
                "type": "protocol non-compliance",
                "reasons": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "2"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "2"
                  }
                ]
              },
              {
                "type": "Other reasons eg. radiation treatment",
                "reasons": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "23"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "20"
                  }
                ]
              }
            ]
          }
        ]
      },
      "baselineCharacteristicsModule": {
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "374",
                "groupId": "BG000"
              },
              {
                "value": "362",
                "groupId": "BG001"
              },
              {
                "value": "736",
                "groupId": "BG002"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "BG000",
            "title": "Fulvestrant 250 mg",
            "description": "Fulvestrant 250 mg Intramuscular Injection every 28 days"
          },
          {
            "id": "BG001",
            "title": "Fulvestrant 500 mg",
            "description": "Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14"
          },
          {
            "id": "BG002",
            "title": "Total",
            "description": "Total of all reporting groups"
          }
        ],
        "measures": [
          {
            "title": "Age Continuous",
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "60.8",
                        "spread": "11.94",
                        "groupId": "BG000"
                      },
                      {
                        "value": "61.0",
                        "spread": "11.47",
                        "groupId": "BG001"
                      },
                      {
                        "value": "60.9",
                        "spread": "11.71",
                        "groupId": "BG002"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEAN",
            "unitOfMeasure": "Years",
            "dispersionType": "STANDARD_DEVIATION"
          },
          {
            "title": "Sex: Female, Male",
            "classes": [
              {
                "categories": [
                  {
                    "title": "Female",
                    "measurements": [
                      {
                        "value": "374",
                        "groupId": "BG000"
                      },
                      {
                        "value": "362",
                        "groupId": "BG001"
                      },
                      {
                        "value": "736",
                        "groupId": "BG002"
                      }
                    ]
                  },
                  {
                    "title": "Male",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG001"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "unitOfMeasure": "Participants"
          }
        ]
      }
    }
  }
]