NCT02576431

A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors

Version 30 to 31 · Bayer

Patch inspector

Version 30 to 31

47 operations 7 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

arms_or_interventions_changeenrollment_count_changeprimary_outcome_any_changesecondary_outcome_any_change

Value signals

[
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_major_slip",
    "category": "timeline_major_slip",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "later",
    "new_value": "2026-10-30",
    "old_value": "2021-05-31",
    "delta_days": 1978,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  },
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_major_slip",
    "category": "timeline_major_slip",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "later",
    "new_value": "2026-10-30",
    "old_value": "2021-05-31",
    "delta_days": 1978,
    "date_struct": "completionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  },
  {
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "signal": "enrollment_count_change_ge_20pct",
    "category": "enrollment_change",
    "severity": "high",
    "new_value": 200,
    "old_value": 320,
    "pct_change": 0.375
  }
]

Provenance

Source: ctgov_internal_history
Fetched: 2026-06-18 19:12:20+00
Raw hash: 25ac6c93fce1e664288ae2a9e6d8d494067557268f33a93b43594548def5f833
Payload: Source URL

Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 1 ops

replace /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame

Triage: Critical

Primary Outcome Change Operation 26

Matched rules

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

Before

Up to 68 months

After

Up to 133 months

Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 15 ops

replace /protocolSection/designModule/enrollmentInfo/count

Triage: High

Enrollment Change Operation 11

Matched rules

enrollment_count_change Enrollment count changes can signal scope or feasibility shifts.

Before

After

replace /protocolSection/armsInterventionsModule/armGroups/0/description

Triage: High

Arm Intervention Change Operation 12

Matched rules

arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.

Before

Patients with solid non-small cell lung cancer (NSCLC) harboring NTRK fusions

After

Patients with solid non-small cell lung cancer (NSCLC) harboring NTRK fusions (arm closed)

replace /protocolSection/armsInterventionsModule/armGroups/1/description

Triage: High

Arm Intervention Change Operation 13

Matched rules

arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.

Before

Patients with solid thyroid tumors harboring NTRK fusions

After

Patients with solid thyroid tumors harboring NTRK fusions (arm closed)

replace /protocolSection/armsInterventionsModule/armGroups/2/description

Triage: High

Arm Intervention Change Operation 14

Matched rules

arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.

Before

Patients with soft-tissue sarcoma harboring NTRK fusions

After

Patients with soft-tissue sarcoma harboring NTRK fusions (arm closed)

replace /protocolSection/armsInterventionsModule/armGroups/4/description

Triage: High

Arm Intervention Change Operation 15

Matched rules

arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.

Before

Patients with solid salivary tumors harboring NTRK fusions

After

Patients with solid salivary tumors harboring NTRK fusions (arm closed)

replace /protocolSection/armsInterventionsModule/armGroups/5/description

Triage: High

Arm Intervention Change Operation 16

Matched rules

arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.

Before

Patients with solid biliary tumors harboring NTRK fusions

After

Patients with solid biliary tumors harboring NTRK fusions (arm closed)

replace /protocolSection/armsInterventionsModule/armGroups/6/description

Triage: High

Arm Intervention Change Operation 17

Matched rules

arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.

Before

Patients with solid tumors in the primary central nervous system (CNS) harboring NTRK fusions

After

Patients with solid tumors in the primary central nervous system (CNS) harboring NTRK fusions (arm closed)

replace /protocolSection/armsInterventionsModule/armGroups/7/description

Triage: High

Arm Intervention Change Operation 18

Matched rules

arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.

Before

Patients with breast cancer, kidney cancer, squamous cell cancer of head or neck, melanoma or ovarian solid tumors harboring NTRK fusions

After

Patients with e.g.
kidney cancer, squamous cell cancer of head or neck or ovarian solid tumors harboring NTRK fusions

replace /protocolSection/armsInterventionsModule/armGroups/8/description

Triage: High

Arm Intervention Change Operation 19

Matched rules

arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.

Before

Patients eligible for arms 1 to 8, but with documented NTRK fusion from a laboratory where CLIA or equivalent certification cannot be confirmed by the sponsor at the time of consent.

After

Patients eligible for arms 1 to 8, but with documented NTRK fusion from a laboratory where CLIA or equivalent certification cannot be confirmed by the sponsor at the time of consent (arm closed)

add /protocolSection/armsInterventionsModule/armGroups/9

Triage: High

Arm Intervention Change Operation 20

Matched rules

arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.

After

{
  "type": "EXPERIMENTAL",
  "label": "Arm 10_Lung cancer",
  "description": "Patients with lung cancer harboring NTRK fusions",
  "interventionNames": [
    "Drug: BAY2757556 (Larotrectinib, Vitrakvi)"
  ]
}

add /protocolSection/armsInterventionsModule/armGroups/10

Triage: High

Arm Intervention Change Operation 21

Matched rules

arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.

After

{
  "type": "EXPERIMENTAL",
  "label": "Arm 11_Melanoma",
  "description": "Patients with melanoma harboring NTRK fusions",
  "interventionNames": [
    "Drug: BAY2757556 (Larotrectinib, Vitrakvi)"
  ]
}

add /protocolSection/armsInterventionsModule/armGroups/11

Triage: High

Arm Intervention Change Operation 22

Matched rules

arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.

After

{
  "type": "EXPERIMENTAL",
  "label": "Arm 12_Breast cancer",
  "description": "Patient with non-secretory breast cancer harboring NTRK fusions",
  "interventionNames": [
    "Drug: BAY2757556 (Larotrectinib, Vitrakvi)"
  ]
}

add /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0

Triage: High

Arm Intervention Change Operation 23

Matched rules

arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.

After

Arm 10_Lung cancer

add /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/1

Triage: High

Arm Intervention Change Operation 24

Matched rules

arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.

After

Arm 11_Melanoma

add /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/2

Triage: High

Arm Intervention Change Operation 25

Matched rules

arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.

After

Arm 12_Breast cancer

Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 20 ops

replace /protocolSection/outcomesModule/secondaryOutcomes/0/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 68 months

After

Up to 133 months

replace /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame

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

Up to 68 months

After

Up to 133 months

replace /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame

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

Up to 68 months

After

Up to 133 months

replace /protocolSection/outcomesModule/secondaryOutcomes/3/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 68 months

After

Up to 133 months

replace /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame

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

Up to 68 months

After

Up to 133 months

replace /protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame

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

Up to 68 months

After

Up to 133 months

replace /protocolSection/outcomesModule/secondaryOutcomes/6/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 68 months

After

Up to 133 months

replace /protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame

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

Up to 68 months

After

Up to 133 months

replace /protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame

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

Up to 68 months

After

Up to 133 months

replace /protocolSection/outcomesModule/secondaryOutcomes/9/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 68 months

After

Up to 133 months

replace /protocolSection/outcomesModule/secondaryOutcomes/10/timeFrame

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

Up to 68 months

After

Up to 133 months

replace /protocolSection/outcomesModule/secondaryOutcomes/11/timeFrame

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

Up to 68 months

After

Up to 133 months

replace /protocolSection/outcomesModule/secondaryOutcomes/12/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 68 months

After

Up to 133 months

replace /protocolSection/outcomesModule/secondaryOutcomes/13/timeFrame

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

Up to 68 months

After

Up to 133 months

replace /protocolSection/outcomesModule/secondaryOutcomes/14/timeFrame

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

Up to 68 months

After

Up to 133 months

replace /protocolSection/outcomesModule/secondaryOutcomes/15/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 68 months

After

Up to 133 months

replace /protocolSection/outcomesModule/secondaryOutcomes/16/timeFrame

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

Up to 68 months

After

Up to 133 months

replace /protocolSection/outcomesModule/secondaryOutcomes/17/timeFrame

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

Up to 68 months

After

Up to 133 months

replace /protocolSection/outcomesModule/secondaryOutcomes/18/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 68 months

After

Up to 133 months

replace /protocolSection/outcomesModule/secondaryOutcomes/19/timeFrame

Triage: High

Secondary Outcome Change Operation 46

Matched rules

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

Before

Up to 68 months

After

Up to 133 months

Timeline Start, primary completion, and completion date movement. Triage: Medium 2 ops

replace /protocolSection/statusModule/primaryCompletionDateStruct/date

Triage: Medium

Timeline Shift Operation 3

Matched rules

primary_completion_timeline_change Primary completion date changes are operational timeline signals.

Before

2021-05-31

After

2026-10-30

replace /protocolSection/statusModule/completionDateStruct/date

Triage: Medium

Timeline Shift Operation 4

Matched rules

completion_timeline_change Completion date changes are operational timeline signals.

Before

2021-05-31

After

2026-10-30

Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 1 ops

add /protocolSection/contactsLocationsModule/locations/31

Triage: Uncategorized

Uncategorized Operation 47

After

{
  "zip": "060-8648",
  "city": "Sapporo",
  "state": "Hokkaido",
  "status": "NOT_YET_RECRUITING",
  "country": "Japan",
  "facility": "Hokkaido University Hospital",
  "geoPoint": {
    "lat": 43.06667,
    "lon": 141.35
  }
}

Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 7 ops

replace /protocolSection/statusModule/statusVerifiedDate

Triage: Uncategorized

Uncategorized Operation 2

Before

2019-10

After

2019-11

replace /protocolSection/statusModule/lastUpdateSubmitDate

Triage: Uncategorized

Uncategorized Operation 5

Before

2019-10-23

After

2019-12-09

replace /protocolSection/statusModule/lastUpdatePostDateStruct/date

Triage: Uncategorized

Uncategorized Operation 6

Before

2019-10-24

After

2019-12-11

replace /protocolSection/descriptionModule/briefSummary

Triage: Uncategorized

Uncategorized Operation 7

Before

This research study is done to test how well different types of cancer respond to the drug called larotrectinib.
The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3).
Larotrectinib is an experimental drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer.

After

This research study is done to test how well different types of cancer respond to the drug called larotrectinib.
The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3).
Larotrectinib is a drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer.

replace /protocolSection/conditionsModule/keywords/6

Triage: Uncategorized

Uncategorized Operation 8

Before

Central nervous system (CNS) tumor

After

Central nervous system (CNS) Tumor

add /protocolSection/conditionsModule/keywords/7

Triage: Uncategorized

Uncategorized Operation 9

After

Breast cancer

add /protocolSection/conditionsModule/keywords/8

Triage: Uncategorized

Uncategorized Operation 10

After

Melanoma

Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 1 ops

replace /protocolSection/identificationModule/officialTitle

Triage: Uncategorized

Uncategorized Operation 1

Before

A Phase II Basket Study of the Oral TRK Inhibitor LOXO-101 in Subjects With NTRK Fusion-positive Tumors

After

A Phase 2 Basket Study of the Oral TRK Inhibitor Larotrectinib in Subjects With NTRK Fusion-positive Tumors

Raw JSON Patch

[
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/officialTitle",
    "value": "A Phase 2 Basket Study of the Oral TRK Inhibitor Larotrectinib in Subjects With NTRK Fusion-positive Tumors"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2019-11"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2026-10-30"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2026-10-30"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2019-12-09"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2019-12-11"
  },
  {
    "op": "replace",
    "path": "/protocolSection/descriptionModule/briefSummary",
    "value": "This research study is done to test how well different types of cancer respond to the drug called larotrectinib.\nThe cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3).\nLarotrectinib is a drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer."
  },
  {
    "op": "replace",
    "path": "/protocolSection/conditionsModule/keywords/6",
    "value": "Central nervous system (CNS) Tumor"
  },
  {
    "op": "add",
    "path": "/protocolSection/conditionsModule/keywords/7",
    "value": "Breast cancer"
  },
  {
    "op": "add",
    "path": "/protocolSection/conditionsModule/keywords/8",
    "value": "Melanoma"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "value": 200
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/description",
    "value": "Patients with solid non-small cell lung cancer (NSCLC) harboring NTRK fusions (arm closed)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/description",
    "value": "Patients with solid thyroid tumors harboring NTRK fusions (arm closed)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2/description",
    "value": "Patients with soft-tissue sarcoma harboring NTRK fusions (arm closed)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/4/description",
    "value": "Patients with solid salivary tumors harboring NTRK fusions (arm closed)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/5/description",
    "value": "Patients with solid biliary tumors harboring NTRK fusions (arm closed)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/6/description",
    "value": "Patients with solid tumors in the primary central nervous system (CNS) harboring NTRK fusions (arm closed)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/7/description",
    "value": "Patients with e.g.\nkidney cancer, squamous cell cancer of head or neck or ovarian solid tumors harboring NTRK fusions"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/8/description",
    "value": "Patients eligible for arms 1 to 8, but with documented NTRK fusion from a laboratory where CLIA or equivalent certification cannot be confirmed by the sponsor at the time of consent (arm closed)"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/9",
    "value": {
      "type": "EXPERIMENTAL",
      "label": "Arm 10_Lung cancer",
      "description": "Patients with lung cancer harboring NTRK fusions",
      "interventionNames": [
        "Drug: BAY2757556 (Larotrectinib, Vitrakvi)"
      ]
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/10",
    "value": {
      "type": "EXPERIMENTAL",
      "label": "Arm 11_Melanoma",
      "description": "Patients with melanoma harboring NTRK fusions",
      "interventionNames": [
        "Drug: BAY2757556 (Larotrectinib, Vitrakvi)"
      ]
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/11",
    "value": {
      "type": "EXPERIMENTAL",
      "label": "Arm 12_Breast cancer",
      "description": "Patient with non-secretory breast cancer harboring NTRK fusions",
      "interventionNames": [
        "Drug: BAY2757556 (Larotrectinib, Vitrakvi)"
      ]
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
    "value": "Arm 10_Lung cancer"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/1",
    "value": "Arm 11_Melanoma"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/2",
    "value": "Arm 12_Breast cancer"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "Up to 133 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "value": "Up to 133 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "value": "Up to 133 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
    "value": "Up to 133 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
    "value": "Up to 133 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
    "value": "Up to 133 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
    "value": "Up to 133 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame",
    "value": "Up to 133 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame",
    "value": "Up to 133 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame",
    "value": "Up to 133 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/9/timeFrame",
    "value": "Up to 133 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/10/timeFrame",
    "value": "Up to 133 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/11/timeFrame",
    "value": "Up to 133 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/12/timeFrame",
    "value": "Up to 133 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/13/timeFrame",
    "value": "Up to 133 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/14/timeFrame",
    "value": "Up to 133 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/15/timeFrame",
    "value": "Up to 133 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/16/timeFrame",
    "value": "Up to 133 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/17/timeFrame",
    "value": "Up to 133 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/18/timeFrame",
    "value": "Up to 133 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/19/timeFrame",
    "value": "Up to 133 months"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/31",
    "value": {
      "zip": "060-8648",
      "city": "Sapporo",
      "state": "Hokkaido",
      "status": "NOT_YET_RECRUITING",
      "country": "Japan",
      "facility": "Hokkaido University Hospital",
      "geoPoint": {
        "lat": 43.06667,
        "lon": 141.35
      }
    }
  }
]