NCT04111107 · OUTCOME
Number of Participants With Adverse Events
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 | Source count |
|---|---|
| Drug Administration Based on Next Gen Sequencing Report | 34 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Drug Administration Based on Next Gen Sequencing Report | 34 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 34
- denoms
- counts
- 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
- 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
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