TriangleNCT00087438 · OUTCOME
Proportion of Subjects With Specified 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
- From randomization to last follow-up. Analysis occurred after all patients had been on study for at least 2 years. Maximum follow-up at time of analysis was 4.2 years.
What was measured
Specified adverse events are defined as any treatment-related adverse events that are grade 4, grade 5, or any of the following treatment-related grade 3 adverse events: * Gastrointestinal: dysphagia, esophagitis, esophageal stricture, esophageal ulceration; * Cardiac: pericarditis, pericardial effusion, cardiomyopathy, ventricular dysfunction; * Neurologic: myelitis, neuropathy (cranial and motor) * Hemorrhage: pulmonary or upper respiratory * Pulmonary: decline in pulmonary function as measured by pulmonary function tests, pneumonitis, pulmonary fibrosis, hypoxemia, pleural effusion. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Analysis population: All eligible patients who started study treatment
Groups in this outcome
Stereotactic Body Radiation Therapy (SBRT)
20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy stereotactic body radiation therapy
| Group | Source count |
|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | 55 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | 9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 9
- denoms
- counts
- group Id
- OG000
- value
- 55
- units
- Participants
- description
- Specified adverse events are defined as any treatment-related adverse events that are grade 4, grade 5, or any of the following treatment-related grade 3 adverse events: * Gastrointestinal: dysphagia, esophagitis, esophageal stricture, esophageal ulceration; * Cardiac: pericarditis, pericardial effusion, cardiomyopathy, ventricular dysfunction; * Neurologic: myelitis, neuropathy (cranial and motor) * Hemorrhage: pulmonary or upper respiratory * Pulmonary: decline in pulmonary function as measured by pulmonary function tests, pneumonitis, pulmonary fibrosis, hypoxemia, pleural effusion. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
- groups
- description
- 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy stereotactic body radiation therapy
- id
- OG000
- title
- Stereotactic Body Radiation Therapy (SBRT)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All eligible patients who started study treatment
- reporting Status
- POSTED
- time Frame
- From randomization to last follow-up. Analysis occurred after all patients had been on study for at least 2 years. Maximum follow-up at time of analysis was 4.2 years.
- title
- Proportion of Subjects With Specified Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice