NCT04224272

A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer

Version 16 to 17 · Jazz Pharmaceuticals

Patch inspector

Version 16 to 17

49 operations 3 path groups ctgov_internal_history

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

None recorded.

Value signals

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Provenance

Source: ctgov_internal_history
Fetched: 2026-06-18 18:58:08+00
Raw hash: fcb9a959a75c41841b3aeb5f47940602577e76c45096a5989c889a1151b5a88b
Payload: Source URL

Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 11 ops

replace /protocolSection/outcomesModule/primaryOutcomes/0/measure

Triage: Critical

Primary Outcome Change Operation 5

Matched rules

primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.

Before

Incidence of dose-limiting toxicities (DLTs; Part 1)

After

Number of Participants With Dose-Limiting Toxicities

replace /protocolSection/outcomesModule/primaryOutcomes/0/description

Triage: Critical

Primary Outcome Change Operation 6

Matched rules

primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.

Before

Number of participants who experienced a DLT.
DLTs include specifically defined adverse events (AEs) considered to be related to ZW25, including combination of ZW25 with palbociclib and&#x2F;or fulvestrant

After

Dose-limiting toxicities, defined using NCI CTCAE version 5.0, are events that 1) occur following administration of ZW25, palbociclib, and fulvestrant, or any combination of ZW25 and 1 or more of these drugs; and 2) meet the criteria as specified in the protocol.

replace /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame

Triage: Critical

Primary Outcome Change Operation 7

Matched rules

primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.

Before

Up to 4 weeks

After

Cycle 1 Day 1 to Day 28 (each cycle is 28 days)

replace /protocolSection/outcomesModule/primaryOutcomes/1/measure

Triage: Critical

Primary Outcome Change Operation 8

Matched rules

primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.

Before

Incidence of AEs (Part 1)

After

Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events

replace /protocolSection/outcomesModule/primaryOutcomes/1/description

Triage: Critical

Primary Outcome Change Operation 9

Matched rules

primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.

Before

Number of participants who experienced AEs, serious adverse events (SAEs), or adverse events of special interest (AESIs)

After

A treatment-emergent adverse event occurs after the start of study treatment and is defined as any unfavorable or unintended symptom, sign, or disease (including abnormal lab) temporally associated with the use of treatment that may or may not be considered related to treatment.
TEAEs were coded using MedDRA v24.0.

replace /protocolSection/outcomesModule/primaryOutcomes/1/timeFrame

Triage: Critical

Primary Outcome Change Operation 10

Matched rules

primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.

Before

Up to 3.5 years

After

Baseline from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.

replace /protocolSection/outcomesModule/primaryOutcomes/2/measure

Triage: Critical

Primary Outcome Change Operation 11

Matched rules

primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.

Before

Incidence of lab abnormalities (Part 1)

After

Progression-free Survival 6

replace /protocolSection/outcomesModule/primaryOutcomes/2/description

Triage: Critical

Primary Outcome Change Operation 12

Matched rules

primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.

Before

Number of participants who experienced a maximum severity of Grade 3 or higher post-baseline lab abnormality, including either hematology or chemistry.
Grades are defined using National Cancer Institute&#x27;s Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

After

Progression-free survival at 6 months (PFS6) is defined as having a progression-free survival time greater than or equal to 24 weeks at the time of analysis where PFS time is defined as the time from the first dose of ZW25, palbociclib, and&#x2F;or fulvestrant to the date of documented disease progression (per RECIST 1.1) or death from any cause.

replace /protocolSection/outcomesModule/primaryOutcomes/2/timeFrame

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

Up to 3.5 years

After

6 months from first dose of any study drug to the date of documented disease progression or death, up to approximately 2 years 10 months

add /protocolSection/outcomesModule/primaryOutcomes/2/reviewUnit

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.

After

{
  "resetReasons": [
    "There does not appear to be sufficient information to understand the Time Frame."
  ]
}

remove /protocolSection/outcomesModule/primaryOutcomes/3

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.

Before

{
  "measure": "Progression-free survival 6 (PFS6; Part 2)",
  "timeFrame": "Up to 6 months",
  "description": "Percent of modified intent to treat patients with PFS greater than or equal to 24 weeks"
}

Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 30 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

Maximum serum concentration of ZW25 (Parts 1 and 2)

After

Number of Participants Reporting Any Treatment-emergent Adverse Event, Serious Adverse Event, and Adverse Event of Special Interest

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

Up to 9 months

After

From the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 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

A treatment-emergent adverse events (TEAEs) was defined as an adverse event (AE) with onset on or after 1st dose of study treatment through 30 days after final dose of study treatment inclusive.
An AE is classified as a serious adverse event (SAE) if fatal, life threatening, requires hospitalization, is disabling&#x2F;incapacitating, causes congenital anomaly or birth defect, and medically significant.
Adverse events of special interest (AESI) include absolute decreases in LVEF greater than or equal to 10 percentage points from baseline, symptomatic heart failure, infusion-related reactions, and all greater than or equal to Grade 2 events of pneumonitis and&#x2F;or interstitial lung disease, including pulmonary fibrosis.

replace /protocolSection/outcomesModule/secondaryOutcomes/1/measure

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.

Before

Trough concentration of ZW25 (Parts 1 and 2)

After

Maximum Serum Concentration of ZW25

remove /protocolSection/outcomesModule/secondaryOutcomes/1/description

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.

Before

Minimum observed serum concentration (trough)

replace /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame

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.

Before

Up to 9 months

After

Cycle 1, Days 1, 2, 5, 15; Cycle 2, Days 1 and 15; Day 1 of all subsequent cycles (each cycle is 28 days); and end of treatment, up to approximately 5 years 4 months

replace /protocolSection/outcomesModule/secondaryOutcomes/2/measure

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.

Before

Incidence of anti-drug antibodies (ADAs) (Parts 1 and 2)

After

Trough Concentration of ZW25

remove /protocolSection/outcomesModule/secondaryOutcomes/2/description

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.

Before

Number of participants who develop ADAs

replace /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame

Triage: High

Secondary Outcome Change Operation 24

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

Up to 10 months

After

Cycle 1, Days 1, 2, 5, 15; Cycle 2, Days 1 and 15; Day 1 of all subsequent cycles (each cycle is 28 days); and end of treatment, up to approximately 5 years 4 months

replace /protocolSection/outcomesModule/secondaryOutcomes/3/measure

Triage: High

Secondary Outcome Change Operation 25

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

Objective response rate (Part 2)

After

Incidence of Anti-drug Antibodies (ADAs)

remove /protocolSection/outcomesModule/secondaryOutcomes/3/description

Triage: High

Secondary Outcome Change Operation 26

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

Number of participants who achieved a best response of either complete response (CR) or partial response (PR) during treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and as assessed by the investigator

replace /protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame

Triage: High

Secondary Outcome Change Operation 27

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

Up to 3.5 years

After

Cycles 1 and 2, Day 15; Day 1 of all subsequent cycles (each cycle is 28 days); end of treatment, 30 days post-last dose (safety follow up), and every 8 weeks (efficacy follow up), up to approximately 5 years 4 months

replace /protocolSection/outcomesModule/secondaryOutcomes/4/measure

Triage: High

Secondary Outcome Change Operation 28

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

Duration of response (Part 2)

After

Objective Response Rate

remove /protocolSection/outcomesModule/secondaryOutcomes/4/description

Triage: High

Secondary Outcome Change Operation 29

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

Time from the first objective response (CR or PR) to documented progressive disease per RECIST 1.1 or death within 30 days of last dose of study drug (ZW25, palbociclib, and&#x2F;or fulvestrant) from any cause

replace /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame

Triage: High

Secondary Outcome Change Operation 30

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

Up to 3.5 years

After

Baseline up to end of study, approximately 5 years 4 months

replace /protocolSection/outcomesModule/secondaryOutcomes/5/measure

Triage: High

Secondary Outcome Change Operation 31

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

Disease control rate (Part 2)

After

Duration of Response

remove /protocolSection/outcomesModule/secondaryOutcomes/5/description

Triage: High

Secondary Outcome Change Operation 32

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

Number of participants who achieved a best response of CR, PR, or stable disease during treatment according to the RECIST version 1.1 and as assessed by the investigator

replace /protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame

Triage: High

Secondary Outcome Change Operation 33

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

Up to 3.5 years

After

Baseline up to end of study, approximately 5 years 4 months

replace /protocolSection/outcomesModule/secondaryOutcomes/6/measure

Triage: High

Secondary Outcome Change Operation 34

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

Progression-free survival (PFS; Part 2)

After

Disease Control Rate

remove /protocolSection/outcomesModule/secondaryOutcomes/6/description

Triage: High

Secondary Outcome Change Operation 35

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

Time from the first dose of ZW25, palbociclib, and&#x2F;or fulvestrant to the date of documented disease progression (per RECIST 1.1), clinical progression, or death from any cause

replace /protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame

Triage: High

Secondary Outcome Change Operation 36

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

Up to 3.5 years

After

Baseline up to end of study, approximately 5 years 4 months

replace /protocolSection/outcomesModule/secondaryOutcomes/7/measure

Triage: High

Secondary Outcome Change Operation 37

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

Overall survival (Part 2)

After

Progression-free Survival

remove /protocolSection/outcomesModule/secondaryOutcomes/7/description

Triage: High

Secondary Outcome Change Operation 38

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

Time from the first dose of ZW25, palbociclib, and&#x2F;or fulvestrant until death from any cause

replace /protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame

Triage: High

Secondary Outcome Change Operation 39

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

Up to 3.5 years

After

Baseline up to end of study, approximately 5 years 4 months

replace /protocolSection/outcomesModule/secondaryOutcomes/8/measure

Triage: High

Secondary Outcome Change Operation 40

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

Incidence of AEs (Part 2)

After

Overall Survival

remove /protocolSection/outcomesModule/secondaryOutcomes/8/description

Triage: High

Secondary Outcome Change Operation 41

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

Number of participants who experienced AEs, SAEs, or AESIs

replace /protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame

Triage: High

Secondary Outcome Change Operation 42

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

Up to 3.5 years

After

Baseline up to end of study, approximately 5 years 4 months

replace /protocolSection/outcomesModule/secondaryOutcomes/9/measure

Triage: High

Secondary Outcome Change Operation 43

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

Incidence of lab abnormalities (Part 2)

After

Incidence of Lab Abnormalities

remove /protocolSection/outcomesModule/secondaryOutcomes/9/description

Triage: High

Secondary Outcome Change Operation 44

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

Number of participants who experienced a maximum severity of Grade 3 or higher post-baseline lab abnormality, including either hematology or chemistry.
Grades are defined using National Cancer Institute&#x27;s CTCAE, version 5.0.

replace /protocolSection/outcomesModule/secondaryOutcomes/9/timeFrame

Triage: High

Secondary Outcome Change Operation 45

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

Up to 3.5 years

After

Baseline up to end of study, approximately 5 years 4 months

Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 8 ops

replace /protocolSection/statusModule/statusVerifiedDate

Triage: Uncategorized

Uncategorized Operation 1

Before

2023-12

After

2024-04

replace /protocolSection/statusModule/lastUpdateSubmitDate

Triage: Uncategorized

Uncategorized Operation 2

Before

2023-12-05

After

2024-04-26

replace /protocolSection/statusModule/lastUpdatePostDateStruct/date

Triage: Uncategorized

Uncategorized Operation 3

Before

2023-12-06

After

2024-05-24

add /protocolSection/statusModule/resultsFirstSubmitDate

Triage: Uncategorized

Uncategorized Operation 4

After

2024-04-26

replace /hasResults

Triage: Uncategorized

Uncategorized Operation 46

Before

false

After

true

add /resultsSection

Triage: Uncategorized

Uncategorized Operation 47

After

{
  "moreInfoModule": {
    "pointOfContact": {
      "email": "ClinicalTrialDisclosure@JazzPharma.com",
      "phone": "215-832-3750",
      "title": "Clinical Trial Disclosure &amp; Transparency",
      "organization": "Jazz Pharmaceuticals Inc."
    },
    "certainAgreement": {
      "piSponsorEmployee": false,
      "restrictiveAgreement": false
    }
  },
  "adverseEventsModule": {
    "timeFrame": "Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.",
    "eventGroups": [
      {
        "id": "EG000",
        "title": "ZW25 (Zanidatamab) + Palbociclib + Fulvestrant",
        "description": "Participants who received an intravenous dose of 20 mg&#x2F;kg ZW25 (zanidatamab) every 2 weeks (Q2W) in combination with an oral administration of 125 mg palbociclib once daily from Days 1 to 21, and an intramuscular injection of 500 mg fulvestrant Q2W for 3 doses (Cycle 1 Days 1 and 15 and Cycle 2 Day 1), and every 4 weeks (Q4W) thereafter.",
        "otherNumAtRisk": 51,
        "deathsNumAtRisk": 51,
        "otherNumAffected": 51,
        "seriousNumAtRisk": 51,
        "deathsNumAffected": 14,
        "seriousNumAffected": 8
      }
    ],
    "otherEvents": [
      {
        "term": "Diarrhoea",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 51,
            "numAffected": 47
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA24"
      },
      {
        "term": "Nausea",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 51,
            "numAffected": 27
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA24"
      },
      {
        "term": "Stomatitis",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 51,
            "numAffected": 21
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA24"
      },
      {
        "term": "Vomiting",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 51,
            "numAffected": 17
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA24"
      },
      {
        "term": "Abdominal pain",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 51,
            "numAffected": 11
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA24"
      },
      {
        "term": "Dyspepsia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 51,
            "numAffected": 8
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA24"
      },
      {
        "term": "Constipation",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 51,
            "numAffected": 5
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA24"
      },
      {
        "term": "Abdominal pain upper",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 51,
            "numAffected": 4
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA24"
      },
      {
        "term": "Abdominal distension",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 51,
            "numAffected": 3
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA24"
      },
      {
        "term": "Asthenia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 51,
            "numAffected": 19
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA24"
      },
      {
        "term": "Fatigue",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 51,
            "numAffected": 10
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA24"
      },
      {
        "term": "Pyrexia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 51,
            "numAffected": 5
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA24"
      },
      {
        "term": "Injection site pain",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 51,
            "numAffected": 3
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA24"
      },
      {
        "term": "Neutropenia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 51,
            "numAffected": 19
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA24"
      },
      {
        "term": "Anaemia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 51,
            "numAffected": 16
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA24"
      },
      {
        "term": "Thrombocytopenia",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 51,
            "numAffected": 8
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
        "sourceVocabulary": "MedDRA24"
      },
      {
        "term": "COVID-19",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 51,
            "numAffected": 10
          }
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        "organSystem": "Infections and infestations",
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      {
        "term": "Pain in extremity",
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      },
      {
        "term": "Arthralgia",
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      {
        "term": "Back pain",
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        ],
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      {
        "term": "Musculoskeletal stiffness",
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      {
        "term": "Epistaxis",
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        ],
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
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      },
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        "term": "Cough",
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        ],
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
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      {
        "term": "Nasal congestion",
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      {
        "term": "Headache",
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        "organSystem": "Nervous system disorders",
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        "term": "Dizziness",
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        "term": "Paraesthesia",
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      {
        "term": "Peripheral sensory neuropathy",
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        "organSystem": "Psychiatric disorders",
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        "term": "COVID-19",
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        "organSystem": "Infections and infestations",
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        "organSystem": "Infections and infestations",
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          }
        ],
        "organSystem": "Infections and infestations",
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      },
      {
        "term": "Staphylococcal bacteraemia",
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        ],
        "organSystem": "Infections and infestations",
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        ],
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
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        "organSystem": "Respiratory, thoracic and mediastinal disorders",
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        "organSystem": "Blood and lymphatic system disorders",
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        ],
        "organSystem": "Metabolism and nutrition disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT",
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      },
      {
        "term": "Acute kidney injury",
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        ],
        "organSystem": "Renal and urinary disorders",
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    ],
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  },
  "outcomeMeasuresModule": {
    "outcomeMeasures": [
      {
        "type": "PRIMARY",
        "title": "Number of Participants With Dose-Limiting Toxicities",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "8",
                "groupId": "OG000"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
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          }
        ],
        "classes": [
          {
            "categories": [
              {
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "timeFrame": "Cycle 1 Day 1 to Day 28 (each cycle is 28 days)",
        "description": "Dose-limiting toxicities, defined using NCI CTCAE version 5.0, are events that 1) occur following administration of ZW25, palbociclib, and fulvestrant, or any combination of ZW25 and 1 or more of these drugs; and 2) meet the criteria as specified in the protocol.",
        "unitOfMeasure": "Participants",
        "reportingStatus": "POSTED",
        "populationDescription": "Dose-limiting toxicities were assessed in participants with available data in the Safety Analysis Set."
      },
      {
        "type": "SECONDARY",
        "title": "Number of Participants Reporting Any Treatment-emergent Adverse Event, Serious Adverse Event, and Adverse Event of Special Interest",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "51",
                "groupId": "OG000"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "OG000",
            "title": "ZW25 (Zanidatamab) + Palbociclib + Fulvestrant",
            "description": "Participants who received an intravenous dose of 20 mg&#x2F;kg ZW25 (zanidatamab) every 2 weeks (Q2W) in combination with an oral administration of 125 mg palbociclib once daily from Days 1 to 21, and an intramuscular injection of 500 mg fulvestrant Q2W for 3 doses (Cycle 1 Days 1 and 15 and Cycle 2 Day 1), and every 4 weeks (Q4W) thereafter."
          }
        ],
        "classes": [
          {
            "title": "TEAE",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "51",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "SAE",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "8",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "AESI",
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              {
                "measurements": [
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                    "value": "10",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "timeFrame": "From the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months",
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        "unitOfMeasure": "Participants",
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      },
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                "groupId": "OG000"
              }
            ]
          }
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        "groups": [
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          }
        ],
        "classes": [
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            "title": "Any Blood and Lymphatic System Disorders AE",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "20",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Neutropenia",
            "categories": [
              {
                "measurements": [
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                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Anaemia",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "6",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Thrombocytopenia",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "3",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Any Gastrointestinal Disorder AE",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "13",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Diarrhoea",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "8",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Abdominal pain",
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              {
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Duodenal ulcer",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Gastric ulcer",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Nausea",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Small intestinal obstruction",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Stomatitis",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Vomiting",
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              {
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Any Investigation AE",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "12",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Neutrophil count decreased",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "11",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Ejection fraction decreased",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Transaminases increased",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "White blood cell count decreased",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Any Metabolism and Nutrition Disorder AE",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "8",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Hypokalaemia",
            "categories": [
              {
                "measurements": [
                  {
                    "value": "4",
                    "groupId": "OG000"
                  }
                ]
              }
            ]
          },
          {
            "title": "Hypomagnesaemia",
            "categories": [
              {
                "measurements": [
                  {
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                "measurements": [
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          },
          {
            "title": "Pyrexia",
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              {
                "measurements": [
                  {
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          {
            "title": "Any Infections and Infestations AE",
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          {
            "title": "COVID-19 pneumonia",
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          },
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          },
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        },
        "description": "Progression-free survival at 6 months (PFS6) is defined as having a progression-free survival time greater than or equal to 24 weeks at the time of analysis where PFS time is defined as the time from the first dose of ZW25, palbociclib, and&#x2F;or fulvestrant to the date of documented disease progression (per RECIST 1.1) or death from any cause.",
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        "title": "Incidence of Anti-drug Antibodies (ADAs)",
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                "measurements": [
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                    "value": "3",
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          {
            "title": "Not Reported",
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          }
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        "unitOfMeasure": "Participants"
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    ],
    "populationDescription": "The baseline demographic characteristics were assessed in the Safety Analysis Set."
  }
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add /annotationSection

Triage: Uncategorized

Uncategorized Operation 48

After

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add /documentSection

Triage: Uncategorized

Uncategorized Operation 49

After

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Raw JSON Patch

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  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame",
    "value": "Baseline up to end of study, approximately 5 years 4 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/9/measure",
    "value": "Incidence of Lab Abnormalities"
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/9/description"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/9/timeFrame",
    "value": "Baseline up to end of study, approximately 5 years 4 months"
  },
  {
    "op": "replace",
    "path": "/hasResults",
    "value": true
  },
  {
    "op": "add",
    "path": "/resultsSection",
    "value": {
      "moreInfoModule": {
        "pointOfContact": {
          "email": "ClinicalTrialDisclosure@JazzPharma.com",
          "phone": "215-832-3750",
          "title": "Clinical Trial Disclosure &amp; Transparency",
          "organization": "Jazz Pharmaceuticals Inc."
        },
        "certainAgreement": {
          "piSponsorEmployee": false,
          "restrictiveAgreement": false
        }
      },
      "adverseEventsModule": {
        "timeFrame": "Adverse events were collected from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.",
        "eventGroups": [
          {
            "id": "EG000",
            "title": "ZW25 (Zanidatamab) + Palbociclib + Fulvestrant",
            "description": "Participants who received an intravenous dose of 20 mg&#x2F;kg ZW25 (zanidatamab) every 2 weeks (Q2W) in combination with an oral administration of 125 mg palbociclib once daily from Days 1 to 21, and an intramuscular injection of 500 mg fulvestrant Q2W for 3 doses (Cycle 1 Days 1 and 15 and Cycle 2 Day 1), and every 4 weeks (Q4W) thereafter.",
            "otherNumAtRisk": 51,
            "deathsNumAtRisk": 51,
            "otherNumAffected": 51,
            "seriousNumAtRisk": 51,
            "deathsNumAffected": 14,
            "seriousNumAffected": 8
          }
        ],
        "otherEvents": [
          {
            "term": "Diarrhoea",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 47
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Nausea",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 27
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Stomatitis",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 21
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Vomiting",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 17
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Abdominal pain",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 11
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Dyspepsia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 8
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Constipation",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 5
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Abdominal pain upper",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 4
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Abdominal distension",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 3
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Asthenia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 19
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Fatigue",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 10
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Pyrexia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 5
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Injection site pain",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 3
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Neutropenia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 19
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Anaemia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 16
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Thrombocytopenia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 8
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "COVID-19",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 10
              }
            ],
            "organSystem": "Infections and infestations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Urinary tract infection",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 9
              }
            ],
            "organSystem": "Infections and infestations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Nasopharyngitis",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 4
              }
            ],
            "organSystem": "Infections and infestations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Decreased appetite",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 12
              }
            ],
            "organSystem": "Metabolism and nutrition disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Hypokalaemia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 10
              }
            ],
            "organSystem": "Metabolism and nutrition disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Hypomagnesaemia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 7
              }
            ],
            "organSystem": "Metabolism and nutrition disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Neutrophil count decreased",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 14
              }
            ],
            "organSystem": "Investigations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Ejection fraction decreased",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 8
              }
            ],
            "organSystem": "Investigations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Platelet count decreased",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 7
              }
            ],
            "organSystem": "Infections and infestations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Weight decreased",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 6
              }
            ],
            "organSystem": "Investigations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "White blood cell count decreased",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 4
              }
            ],
            "organSystem": "Investigations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Blood alkaline phosphatase increased",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 3
              }
            ],
            "organSystem": "Investigations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Rash",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 9
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Pruritus",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 5
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Alopecia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 4
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Rash maculo-papular",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 4
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Dry skin",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 3
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Muscle spasms",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 9
              }
            ],
            "organSystem": "Musculoskeletal and connective tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Pain in extremity",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 5
              }
            ],
            "organSystem": "Musculoskeletal and connective tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Arthralgia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 4
              }
            ],
            "organSystem": "Musculoskeletal and connective tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Back pain",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 4
              }
            ],
            "organSystem": "Musculoskeletal and connective tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Musculoskeletal stiffness",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 3
              }
            ],
            "organSystem": "Musculoskeletal and connective tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Epistaxis",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 10
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Cough",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 5
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Nasal congestion",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 3
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Headache",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 9
              }
            ],
            "organSystem": "Nervous system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Dizziness",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 5
              }
            ],
            "organSystem": "Nervous system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Paraesthesia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 4
              }
            ],
            "organSystem": "Nervous system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Peripheral sensory neuropathy",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 3
              }
            ],
            "organSystem": "Nervous system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Insomnia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 3
              }
            ],
            "organSystem": "Psychiatric disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Hot flush",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 5
              }
            ],
            "organSystem": "Vascular disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          }
        ],
        "seriousEvents": [
          {
            "term": "Duodenal ulcer",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 1
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Gastric ulcer",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 1
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Small intestinal obstruction",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 1
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "COVID-19",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 1
              }
            ],
            "organSystem": "Infections and infestations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "COVID-19 pneumonia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 1
              }
            ],
            "organSystem": "Infections and infestations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Psoas abscess",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 1
              }
            ],
            "organSystem": "Infections and infestations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Staphylococcal bacteraemia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 1
              }
            ],
            "organSystem": "Infections and infestations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Pleural effusion",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 1
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Pneumothorax",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 1
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Anaemia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 1
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Transaminases increased",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 1
              }
            ],
            "organSystem": "Investigations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Hypercalcaemia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 1
              }
            ],
            "organSystem": "Metabolism and nutrition disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          },
          {
            "term": "Acute kidney injury",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 51,
                "numAffected": 1
              }
            ],
            "organSystem": "Renal and urinary disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT",
            "sourceVocabulary": "MedDRA24"
          }
        ],
        "frequencyThreshold": "5"
      },
      "outcomeMeasuresModule": {
        "outcomeMeasures": [
          {
            "type": "PRIMARY",
            "title": "Number of Participants With Dose-Limiting Toxicities",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "8",
                    "groupId": "OG000"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "ZW25 (Zanidatamab) + Palbociclib + Fulvestrant",
                "description": "Participants who received intravenous dose of 20 mg&#x2F;kg ZW25 (zanidatamab) every 2 weeks (Q2W) in combination with an oral administration of 125 mg palbociclib once daily from Days 1 to 21, and an intramuscular injection of 500 mg fulvestrant Q2W for 3 doses (Cycle 1 Days 1 and 15 and Cycle 2 Day 1), and every 4 weeks (Q4W) thereafter."
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "timeFrame": "Cycle 1 Day 1 to Day 28 (each cycle is 28 days)",
            "description": "Dose-limiting toxicities, defined using NCI CTCAE version 5.0, are events that 1) occur following administration of ZW25, palbociclib, and fulvestrant, or any combination of ZW25 and 1 or more of these drugs; and 2) meet the criteria as specified in the protocol.",
            "unitOfMeasure": "Participants",
            "reportingStatus": "POSTED",
            "populationDescription": "Dose-limiting toxicities were assessed in participants with available data in the Safety Analysis Set."
          },
          {
            "type": "SECONDARY",
            "title": "Number of Participants Reporting Any Treatment-emergent Adverse Event, Serious Adverse Event, and Adverse Event of Special Interest",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "51",
                    "groupId": "OG000"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "ZW25 (Zanidatamab) + Palbociclib + Fulvestrant",
                "description": "Participants who received an intravenous dose of 20 mg&#x2F;kg ZW25 (zanidatamab) every 2 weeks (Q2W) in combination with an oral administration of 125 mg palbociclib once daily from Days 1 to 21, and an intramuscular injection of 500 mg fulvestrant Q2W for 3 doses (Cycle 1 Days 1 and 15 and Cycle 2 Day 1), and every 4 weeks (Q4W) thereafter."
              }
            ],
            "classes": [
              {
                "title": "TEAE",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "51",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "SAE",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "8",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "AESI",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "10",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "timeFrame": "From the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months",
            "description": "A treatment-emergent adverse events (TEAEs) was defined as an adverse event (AE) with onset on or after 1st dose of study treatment through 30 days after final dose of study treatment inclusive.\nAn AE is classified as a serious adverse event (SAE) if fatal, life threatening, requires hospitalization, is disabling&#x2F;incapacitating, causes congenital anomaly or birth defect, and medically significant.\nAdverse events of special interest (AESI) include absolute decreases in LVEF greater than or equal to 10 percentage points from baseline, symptomatic heart failure, infusion-related reactions, and all greater than or equal to Grade 2 events of pneumonitis and&#x2F;or interstitial lung disease, including pulmonary fibrosis.",
            "unitOfMeasure": "Participants",
            "reportingStatus": "POSTED",
            "populationDescription": "Safety data were assessed in the Safety Analysis Set."
          },
          {
            "type": "PRIMARY",
            "title": "Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "51",
                    "groupId": "OG000"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "ZW25 (Zanidatamab) + Palbociclib + Fulvestrant",
                "description": "Participants who received an intravenous dose of 20 mg&#x2F;kg ZW25 (zanidatamab) every 2 weeks (Q2W) in combination with an oral administration of 125 mg palbociclib once daily from Days 1 to 21, and an intramuscular injection of 500 mg fulvestrant Q2W for 3 doses (Cycle 1 Days 1 and 15 and Cycle 2 Day 1), and every 4 weeks (Q4W) thereafter."
              }
            ],
            "classes": [
              {
                "title": "Any Blood and Lymphatic System Disorders AE",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "20",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Neutropenia",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "16",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Anaemia",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "6",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Thrombocytopenia",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "3",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Any Gastrointestinal Disorder AE",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "13",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Diarrhoea",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "8",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Abdominal pain",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Duodenal ulcer",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Gastric ulcer",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Nausea",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Small intestinal obstruction",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Stomatitis",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Vomiting",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Any Investigation AE",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "12",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Neutrophil count decreased",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "11",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Ejection fraction decreased",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Transaminases increased",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "White blood cell count decreased",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Any Metabolism and Nutrition Disorder AE",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "8",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Hypokalaemia",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "4",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Hypomagnesaemia",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "3",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Hypercalcaemia",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "2",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Any General Disorders and Administration Site Conditions AE",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "2",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Fatigue",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Pyrexia",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Any Infections and Infestations AE",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "2",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "COVID-19 pneumonia",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Psoas abscess",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Staphylococcal bacteraemia",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Any Respiratory, Thoracic and Mediastinal Disorder AE",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "2",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Pleural effusion",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Pneumothorax",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Any Renal and Urinary Disorder AE",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Acute kidney injury",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Any Skin and Subcutaneous Tissue Disorder AE",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Rash maculo-papular",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "timeFrame": "Baseline from the start of dosing of any study drug up until 30 days after last study dose, up to approximately 2 years 10 months.",
            "description": "A treatment-emergent adverse event occurs after the start of study treatment and is defined as any unfavorable or unintended symptom, sign, or disease (including abnormal lab) temporally associated with the use of treatment that may or may not be considered related to treatment.\nTEAEs were coded using MedDRA v24.0.",
            "unitOfMeasure": "Participants",
            "reportingStatus": "POSTED",
            "populationDescription": "Treatment-emergent adverse events were assessed in the Safety Analysis Set."
          },
          {
            "type": "PRIMARY",
            "title": "Progression-free Survival 6",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "51",
                    "groupId": "OG000"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "ZW25 (Zanidatamab) + Palbociclib + Fulvestrant",
                "description": "Participants who received an intravenous dose of 20 mg&#x2F;kg ZW25 (zanidatamab) every 2 weeks (Q2W) in combination with an oral administration of 125 mg palbociclib once daily from Days 1 to 21, and an intramuscular injection of 500 mg fulvestrant Q2W for 3 doses (Cycle 1 Days 1 and 15 and Cycle 2 Day 1), and every 4 weeks (Q4W) thereafter."
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "34",
                        "groupId": "OG000"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "timeFrame": "6 months from first dose of any study drug to the date of documented disease progression or death, up to approximately 2 years 10 months",
            "reviewUnit": {
              "resetReasons": [
                "There does not appear to be sufficient information to understand the Time Frame."
              ]
            },
            "description": "Progression-free survival at 6 months (PFS6) is defined as having a progression-free survival time greater than or equal to 24 weeks at the time of analysis where PFS time is defined as the time from the first dose of ZW25, palbociclib, and&#x2F;or fulvestrant to the date of documented disease progression (per RECIST 1.1) or death from any cause.",
            "unitOfMeasure": "Participants",
            "reportingStatus": "POSTED",
            "populationDescription": "Progression-free survival 6 will be assessed in the Safety Analysis Set."
          },
          {
            "type": "SECONDARY",
            "title": "Maximum Serum Concentration of ZW25",
            "timeFrame": "Cycle 1, Days 1, 2, 5, 15; Cycle 2, Days 1 and 15; Day 1 of all subsequent cycles (each cycle is 28 days); and end of treatment, up to approximately 5 years 4 months",
            "reportingStatus": "NOT_POSTED",
            "denomUnitsSelected": "Participants",
            "anticipatedPostingDate": "2026-10"
          },
          {
            "type": "SECONDARY",
            "title": "Trough Concentration of ZW25",
            "timeFrame": "Cycle 1, Days 1, 2, 5, 15; Cycle 2, Days 1 and 15; Day 1 of all subsequent cycles (each cycle is 28 days); and end of treatment, up to approximately 5 years 4 months",
            "reportingStatus": "NOT_POSTED",
            "denomUnitsSelected": "Participants",
            "anticipatedPostingDate": "2026-10"
          },
          {
            "type": "SECONDARY",
            "title": "Incidence of Anti-drug Antibodies (ADAs)",
            "timeFrame": "Cycles 1 and 2, Day 15; Day 1 of all subsequent cycles (each cycle is 28 days); end of treatment, 30 days post-last dose (safety follow up), and every 8 weeks (efficacy follow up), up to approximately 5 years 4 months",
            "reportingStatus": "NOT_POSTED",
            "denomUnitsSelected": "Participants",
            "anticipatedPostingDate": "2026-10"
          },
          {
            "type": "SECONDARY",
            "title": "Objective Response Rate",
            "timeFrame": "Baseline up to end of study, approximately 5 years 4 months",
            "reportingStatus": "NOT_POSTED",
            "denomUnitsSelected": "Participants",
            "anticipatedPostingDate": "2026-10"
          },
          {
            "type": "SECONDARY",
            "title": "Duration of Response",
            "timeFrame": "Baseline up to end of study, approximately 5 years 4 months",
            "reportingStatus": "NOT_POSTED",
            "denomUnitsSelected": "Participants",
            "anticipatedPostingDate": "2026-10"
          },
          {
            "type": "SECONDARY",
            "title": "Disease Control Rate",
            "timeFrame": "Baseline up to end of study, approximately 5 years 4 months",
            "reportingStatus": "NOT_POSTED",
            "denomUnitsSelected": "Participants",
            "anticipatedPostingDate": "2026-10"
          },
          {
            "type": "SECONDARY",
            "title": "Progression-free Survival",
            "timeFrame": "Baseline up to end of study, approximately 5 years 4 months",
            "reportingStatus": "NOT_POSTED",
            "denomUnitsSelected": "Participants",
            "anticipatedPostingDate": "2026-10"
          },
          {
            "type": "SECONDARY",
            "title": "Overall Survival",
            "timeFrame": "Baseline up to end of study, approximately 5 years 4 months",
            "reportingStatus": "NOT_POSTED",
            "denomUnitsSelected": "Participants",
            "anticipatedPostingDate": "2026-10"
          },
          {
            "type": "SECONDARY",
            "title": "Incidence of Lab Abnormalities",
            "timeFrame": "Baseline up to end of study, approximately 5 years 4 months",
            "reportingStatus": "NOT_POSTED",
            "denomUnitsSelected": "Participants",
            "anticipatedPostingDate": "2026-10"
          }
        ]
      },
      "participantFlowModule": {
        "groups": [
          {
            "id": "FG000",
            "title": "ZW25 (Zanidatamab) + Palbociclib + Fulvestrant",
            "description": "Participants who received an intravenous dose of 20 mg&#x2F;kg ZW25 (zanidatamab) every 2 weeks (Q2W) in combination with an oral administration of 125 mg palbociclib once daily from Days 1 to 21, and an intramuscular injection of 500 mg fulvestrant Q2W for 3 doses (Cycle 1 Days 1 and 15 and Cycle 2 Day 1), and every 4 weeks (Q4W) thereafter."
          }
        ],
        "periods": [
          {
            "title": "Part 1 - Dose Finding",
            "milestones": [
              {
                "type": "STARTED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "8"
                  }
                ]
              },
              {
                "type": "COMPLETED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "1"
                  }
                ]
              },
              {
                "type": "NOT COMPLETED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "7"
                  }
                ]
              }
            ],
            "dropWithdraws": [
              {
                "type": "Death",
                "reasons": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "4"
                  }
                ]
              },
              {
                "type": "Withdrawal by Subject",
                "reasons": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "2"
                  }
                ]
              },
              {
                "type": "Lost to Follow-up",
                "reasons": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "1"
                  }
                ]
              }
            ]
          },
          {
            "title": "Part 2 - Dose Expansion",
            "milestones": [
              {
                "type": "STARTED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "43"
                  }
                ]
              },
              {
                "type": "COMPLETED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "30"
                  }
                ]
              },
              {
                "type": "NOT COMPLETED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "13"
                  }
                ]
              }
            ],
            "dropWithdraws": [
              {
                "type": "Death",
                "reasons": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "10"
                  }
                ]
              },
              {
                "type": "Withdrawal by Subject",
                "reasons": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "3"
                  }
                ]
              }
            ]
          }
        ],
        "recruitmentDetails": "A total of 51 participants who met all eligibility criteria were enrolled and received treatment."
      },
      "baselineCharacteristicsModule": {
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "51",
                "groupId": "BG000"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "BG000",
            "title": "ZW25 (Zanidatamab) + Palbociclib + Fulvestrant",
            "description": "Participants who received intravenous dose of 20 mg&#x2F;kg ZW25 (zanidatamab) every 2 weeks (Q2W) in combination with an oral administration of 125 mg palbociclib once daily from Days 1 to 21, and an intramuscular injection of 500 mg fulvestrant Q2W for 3 doses (Cycle 1 Days 1 and 15 and Cycle 2 Day 1), and every 4 weeks (Q4W) thereafter."
          }
        ],
        "measures": [
          {
            "title": "Age, Continuous",
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "54.7",
                        "spread": "10.9",
                        "groupId": "BG000"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEAN",
            "unitOfMeasure": "years",
            "dispersionType": "STANDARD_DEVIATION"
          },
          {
            "title": "Sex: Female, Male",
            "classes": [
              {
                "categories": [
                  {
                    "title": "Female",
                    "measurements": [
                      {
                        "value": "49",
                        "groupId": "BG000"
                      }
                    ]
                  },
                  {
                    "title": "Male",
                    "measurements": [
                      {
                        "value": "2",
                        "groupId": "BG000"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "unitOfMeasure": "Participants"
          },
          {
            "title": "Race&#x2F;Ethnicity, Customized",
            "classes": [
              {
                "title": "Asian",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "2",
                        "groupId": "BG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Black or African American",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "BG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "White",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "42",
                        "groupId": "BG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Multiple",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "BG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Other",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "BG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Unknown",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "3",
                        "groupId": "BG000"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Not Reported",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "BG000"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "unitOfMeasure": "Participants"
          }
        ],
        "populationDescription": "The baseline demographic characteristics were assessed in the Safety Analysis Set."
      }
    }
  },
  {
    "op": "add",
    "path": "/annotationSection",
    "value": {
      "annotationModule": {
        "unpostedAnnotation": {
          "unpostedEvents": [
            {
              "date": "2024-05-23",
              "type": "RESET"
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          ],
          "unpostedResponsibleParty": "Jazz Pharmaceuticals"
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  },
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    "path": "/documentSection",
    "value": {
      "largeDocumentModule": {
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