NCT04111107 · ADVERSE EVENTS
Adverse events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.
- Collection time frame
- Participants were followed for adverse events a minimum of 30 days after date of last study drug administration up to 33 months.
- Other-event reporting threshold
- 5%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Drug Administration Based on Next Gen Sequencing Report | 18 / 34 | 34 / 34 | 32 / 34 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 34
- num Events
- 1
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 34
- num Events
- 1
- term
- Pericardial effusion
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 34
- num Events
- 1
- term
- Retinal detachment
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 34
- num Events
- 1
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 34
- num Events
- 1
- term
- Duodenal hemorrhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 34
- num Events
- 2
- term
- Dysphagia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 34
- num Events
- 1
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 34
- num Events
- 2
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 34
- num Events
- 1
- term
- Chills
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 34
- num Events
- 2
- term
- Disease Progression
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 34
- num Events
- 1
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 34
- num Events
- 1
- term
- Fever
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 13
- num At Risk
- 34
- num Events
- 34
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 34
- num Events
- 3
- term
- Heart Failure
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 34
- num Events
- 9
- term
- Sinus tachycardia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 34
- num Events
- 4
- term
- Vision decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 34
- num Events
- 7
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 34
- num Events
- 7
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 11
- num At Risk
- 34
- num Events
- 12
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 34
- num Events
- 4
- term
- Dysphagia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 34
- num Events
- 2
- term
- Gastroesophageal reflux disease
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 34
- num Events
- 2
- term
- Mucositis oral
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 34
- num Events
- 14
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 34
- num Events
- 2
- term
- Rectal- hemorrhage
Complete source fields
- event Groups
- deaths Num Affected
- 32
- deaths Num At Risk
- 34
- 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
- EG000
- other Num Affected
- 34
- other Num At Risk
- 34
- serious Num Affected
- 18
- serious Num At Risk
- 34
- title
- Drug Administration Based on Next Gen Sequencing Report
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 13
- num At Risk
- 34
- num Events
- 34
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 34
- num Events
- 3
- term
- Heart Failure
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 34
- num Events
- 9
- term
- Sinus tachycardia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 34
- num Events
- 4
- term
- Vision decreased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 34
- num Events
- 7
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 34
- num Events
- 7
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 11
- num At Risk
- 34
- num Events
- 12
- term
- Diarrhea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 34
- num Events
- 4
- term
- Dysphagia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 34
- num Events
- 2
- term
- Gastroesophageal reflux disease
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 34
- num Events
- 2
- term
- Mucositis oral
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 34
- num Events
- 14
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 34
- num Events
- 2
- term
- Rectal- hemorrhage
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 34
- num Events
- 1
- term
- Anemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 34
- num Events
- 1
- term
- Pericardial effusion
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 34
- num Events
- 1
- term
- Retinal detachment
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 34
- num Events
- 1
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 34
- num Events
- 1
- term
- Duodenal hemorrhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 34
- num Events
- 2
- term
- Dysphagia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 34
- num Events
- 1
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 34
- num Events
- 2
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 34
- num Events
- 1
- term
- Chills
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 34
- num Events
- 2
- term
- Disease Progression
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 34
- num Events
- 1
- term
- Fatigue
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 34
- num Events
- 1
- term
- Fever
- time Frame
- Participants were followed for adverse events a minimum of 30 days after date of last study drug administration up to 33 months.
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