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NCT04111107 · OUTCOME

Number of Participants With Adverse Events

Precision Medicine for Patients With Identified Actionable Mutations · Source last updated 2024-07-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 30 days after treatment ends, up to 33 months

What was measured

Adverse events will be summarized in incidence tables by type for all patients who received at least one cycle of treatment.

Analysis population: Eleven patients did not begin treatment under this protocol.

Groups in this outcome

Drug Administration Based on Next Gen Sequencing Report

Investigators will select the first drug listed in the tumor analysis report for the first mutation listed in the tumor analysis report. However, If the subject has a medical contraindication to the first listed drug (according to the drug label) or the first listed drug cannot be obtained for the patient, the study team will select the next drug presented by the tumor sequencing report. Patients receive targeted therapy based on next generation sequencing report. Cycles repeat every 2, 4, or 6 weeks in the absence of disease progression or unacceptable toxicity. Investigational Agent: Treatment will be administered on an inpatient or outpatient basis based on the type of medication selected. The investigatory will administer the drug as directed in the FDA approved label. Supportive Care Regimens: Supportive care regimens will vary depending on the type of drug that will be administered at the treating investigator's discretion. Next Gen Sequencing Report: 1) Next Gen Sequencing report obtained as Standard of Care within the past 12 months of enrollment date will be used. If more than one report exists in this time period, the most recent report will be used.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Drug Administration Based on Next Gen Sequencing Report34

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Drug Administration Based on Next Gen Sequencing Report34Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        34
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    units
    Participants
description
Adverse events will be summarized in incidence tables by type for all patients who received at least one cycle of treatment.
groups
  1. description
    Investigators will select the first drug listed in the tumor analysis report for the first mutation listed in the tumor analysis report. However, If the subject has a medical contraindication to the first listed drug (according to the drug label) or the first listed drug cannot be obtained for the patient, the study team will select the next drug presented by the tumor sequencing report. Patients receive targeted therapy based on next generation sequencing report. Cycles repeat every 2, 4, or 6 weeks in the absence of disease progression or unacceptable toxicity. Investigational Agent: Treatment will be administered on an inpatient or outpatient basis based on the type of medication selected. The investigatory will administer the drug as directed in the FDA approved label. Supportive Care Regimens: Supportive care regimens will vary depending on the type of drug that will be administered at the treating investigator's discretion. Next Gen Sequencing Report: 1) Next Gen Sequencing report obtained as Standard of Care within the past 12 months of enrollment date will be used. If more than one report exists in this time period, the most recent report will be used.
    id
    OG000
    title
    Drug Administration Based on Next Gen Sequencing Report
param Type
COUNT_OF_PARTICIPANTS
population Description
Eleven patients did not begin treatment under this protocol.
reporting Status
POSTED
time Frame
Up to 30 days after treatment ends, up to 33 months
title
Number of Participants With Adverse Events
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice