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NCT02576431

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

Version 31 to 32 · Bayer

Patch inspector

Version 31 to 32

30 operations 6 path groups ctgov_internal_history
ClinicalTrials.gov
Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip the pipeline's suppression passes); the authoritative classification is the stored event record.
Plain-language summary

Manual review pending.

Rules fired
enrollment_count_changeprimary_outcome_any_changesecondary_outcome_any_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_earlier_shift",
    "category": "timeline_shift",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "earlier",
    "new_value": "2025-09-30",
    "old_value": "2026-10-30",
    "delta_days": 395,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  },
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_earlier_shift",
    "category": "timeline_shift",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "earlier",
    "new_value": "2025-09-30",
    "old_value": "2026-10-30",
    "delta_days": 395,
    "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": 120,
    "old_value": 200,
    "pct_change": 0.4
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:12:21+00
Raw hash
c1e1157f0204e90e8ec07346aa451ad2c0b125efa78189f8c6cf377b96bb7985
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 7
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Up to 133 months
After
Up to 120 months
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 1 ops
replace /protocolSection/designModule/enrollmentInfo/count
Triage: High
Enrollment Change Operation 6
Matched rules
  • enrollment_count_change Enrollment count changes can signal scope or feasibility shifts.
Before
200
After
120
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 20 ops
replace /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame
Triage: High
Secondary Outcome Change Operation 8
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Up to 133 months
After
Up to 120 months
replace /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame
Triage: High
Secondary Outcome Change Operation 9
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Up to 133 months
After
Up to 120 months
replace /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame
Triage: High
Secondary Outcome Change Operation 10
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Up to 133 months
After
Up to 120 months
replace /protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame
Triage: High
Secondary Outcome Change Operation 11
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Up to 133 months
After
Up to 120 months
replace /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame
Triage: High
Secondary Outcome Change Operation 12
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Up to 133 months
After
Up to 120 months
replace /protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame
Triage: High
Secondary Outcome Change Operation 13
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Up to 133 months
After
Up to 120 months
replace /protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame
Triage: High
Secondary Outcome Change Operation 14
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Up to 133 months
After
Up to 120 months
replace /protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame
Triage: High
Secondary Outcome Change Operation 15
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Up to 133 months
After
Up to 120 months
replace /protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame
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
Up to 133 months
After
Up to 120 months
replace /protocolSection/outcomesModule/secondaryOutcomes/9/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 133 months
After
Up to 120 months
replace /protocolSection/outcomesModule/secondaryOutcomes/10/timeFrame
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.
Before
Up to 133 months
After
Up to 120 months
replace /protocolSection/outcomesModule/secondaryOutcomes/11/timeFrame
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
Up to 133 months
After
Up to 120 months
replace /protocolSection/outcomesModule/secondaryOutcomes/12/timeFrame
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
Up to 133 months
After
Up to 120 months
replace /protocolSection/outcomesModule/secondaryOutcomes/13/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 133 months
After
Up to 120 months
replace /protocolSection/outcomesModule/secondaryOutcomes/14/timeFrame
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
Up to 133 months
After
Up to 120 months
replace /protocolSection/outcomesModule/secondaryOutcomes/15/timeFrame
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
Up to 133 months
After
Up to 120 months
replace /protocolSection/outcomesModule/secondaryOutcomes/16/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 133 months
After
Up to 120 months
replace /protocolSection/outcomesModule/secondaryOutcomes/17/timeFrame
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
Up to 133 months
After
Up to 120 months
replace /protocolSection/outcomesModule/secondaryOutcomes/18/timeFrame
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
Up to 133 months
After
Up to 120 months
replace /protocolSection/outcomesModule/secondaryOutcomes/19/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 133 months
After
Up to 120 months
Timeline Start, primary completion, and completion date movement. Triage: Medium 2 ops
replace /protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
Timeline Shift Operation 2
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2026-10-30
After
2025-09-30
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 3
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2026-10-30
After
2025-09-30
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 3 ops
replace /protocolSection/contactsLocationsModule/locations/37/status
Triage: Uncategorized
Uncategorized Operation 28
Before
NOT_YET_RECRUITING
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/42
Triage: Uncategorized
Uncategorized Operation 29
After
{
  "zip": "39008",
  "city": "Santander",
  "status": "NOT_YET_RECRUITING",
  "country": "Spain",
  "facility": "Hospital Universitario "Marqués de Valdecilla"",
  "geoPoint": {
    "lat": 43.46589,
    "lon": -3.80493
  }
}
add /protocolSection/contactsLocationsModule/locations/43
Triage: Uncategorized
Uncategorized Operation 30
After
{
  "zip": "46014",
  "city": "Valencia",
  "status": "NOT_YET_RECRUITING",
  "country": "Spain",
  "facility": "Hospital General Universitario de Valencia",
  "geoPoint": {
    "lat": 39.47391,
    "lon": -0.37966
  }
}
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 3 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2019-11
After
2020-01
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 4
Before
2019-12-09
After
2020-01-10
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 5
Before
2019-12-11
After
2020-01-13
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2020-01"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2025-09-30"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2025-09-30"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2020-01-10"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2020-01-13"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "value": 120
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "Up to 120 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "value": "Up to 120 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "value": "Up to 120 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
    "value": "Up to 120 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
    "value": "Up to 120 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
    "value": "Up to 120 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
    "value": "Up to 120 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame",
    "value": "Up to 120 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame",
    "value": "Up to 120 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame",
    "value": "Up to 120 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/9/timeFrame",
    "value": "Up to 120 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/10/timeFrame",
    "value": "Up to 120 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/11/timeFrame",
    "value": "Up to 120 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/12/timeFrame",
    "value": "Up to 120 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/13/timeFrame",
    "value": "Up to 120 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/14/timeFrame",
    "value": "Up to 120 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/15/timeFrame",
    "value": "Up to 120 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/16/timeFrame",
    "value": "Up to 120 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/17/timeFrame",
    "value": "Up to 120 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/18/timeFrame",
    "value": "Up to 120 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/19/timeFrame",
    "value": "Up to 120 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/37/status",
    "value": "RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/42",
    "value": {
      "zip": "39008",
      "city": "Santander",
      "status": "NOT_YET_RECRUITING",
      "country": "Spain",
      "facility": "Hospital Universitario "Marqués de Valdecilla"",
      "geoPoint": {
        "lat": 43.46589,
        "lon": -3.80493
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/43",
    "value": {
      "zip": "46014",
      "city": "Valencia",
      "status": "NOT_YET_RECRUITING",
      "country": "Spain",
      "facility": "Hospital General Universitario de Valencia",
      "geoPoint": {
        "lat": 39.47391,
        "lon": -0.37966
      }
    }
  }
]