TriangleNCT00028002 · OUTCOME
Percentage of Patients With Major Toxicity (Toxicity Grade ≥ 3)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Analysis occurs after all patients have been on study for at least 2 years. Measured from start of treatment to end of follow-up, to a maximum of 4.95 years.
What was measured
Highest grade toxicity per subject was counted. Toxicities were graded using Common Toxicity Criteria (CTC) v 2.0. Grade refers to the severity of the toxicity, using Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.
Analysis population: All eligible patients who started study treatment (for pre-surgery), and who additionally had surgery (post-surgery)
Groups in this outcome
Imatinib Mesylate
Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
| Group | Source count |
|---|---|
| Imatinib Mesylate | 52 |
Reported measurements
Pre-surgery
| Group | Source count |
|---|---|
| Imatinib Mesylate | 52 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Imatinib Mesylate | 34.6 | Not reported | 22.0 | 49.1 | Not reported |
Post-surgery
| Group | Source count |
|---|---|
| Imatinib Mesylate | 45 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Imatinib Mesylate | 48.9 | Not reported | 33.7 | 64.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 22.0
- upper Limit
- 49.1
- value
- 34.6
- denoms
- counts
- group Id
- OG000
- value
- 52
- units
- Participants
- title
- Pre-surgery
- categories
- measurements
- group Id
- OG000
- lower Limit
- 33.7
- upper Limit
- 64.2
- value
- 48.9
- denoms
- counts
- group Id
- OG000
- value
- 45
- units
- Participants
- title
- Post-surgery
- denoms
- counts
- group Id
- OG000
- value
- 52
- units
- Participants
- description
- Highest grade toxicity per subject was counted. Toxicities were graded using Common Toxicity Criteria (CTC) v 2.0. Grade refers to the severity of the toxicity, using Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
- id
- OG000
- title
- Imatinib Mesylate
- param Type
- NUMBER
- population Description
- All eligible patients who started study treatment (for pre-surgery), and who additionally had surgery (post-surgery)
- reporting Status
- POSTED
- time Frame
- Analysis occurs after all patients have been on study for at least 2 years. Measured from start of treatment to end of follow-up, to a maximum of 4.95 years.
- title
- Percentage of Patients With Major Toxicity (Toxicity Grade ≥ 3)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice